211uSTATE OF CALIFORNIA HEALHI ANO HUMAN SERVICES AGENCY
DEPARTMENT OF PUBLIC HEALTH
FOOD liND DRUG BRANCH
Medloal Dovl~o Safely Unit
MEDICAL DEVICE MANUFACTURING INSPECTION REPORT
lnapectlon Oato(o): _2L1Sf201G and 2122/2Q16
Firm Nomo: Big John ProeJucts, Inc,
DBA:
Stroet Addros8: 8533 Canoga Ave" Suite 0 Web Site (URL): www.bigjohnproducls.com
City: Canoga Park Zip Code: \)1304 Phone U: (323) 656-5636
InlorvlawodlTllle: Scott Kramer/President:
U a/Secretary
Ownor,hlp Typo: I8J Corporotlon (Statd:) 0 LLC IState: CAl 0 Partnership 0 Proprlotary 0 co-ownerentp 0 Unknown
OwnorshlptrlUo: Big John Products, Inc,
o Nllw t.lcanse 0 New Llcense Relnspocllon [J ROl1owal o Roinspoctlon o Complaint lnv o Reelli! Inv
f8) Other: Unlicensed Firm InVe&ligallo~~._ ...... _
LICENSE INFORMATION;
FDB Device License tl: 784\7 FDA CFN II: FDA FEI II:
Other FOB LielRug (I: o Cosmetic OPFR o Drug
I] HMOR 0 Other:
BUSINESS INFORMATION:
No, 01 ElliployaoB: 3 Facility Size: '1600 sq. It. Years III Bustnese: ___
4 years
o·p _
IntoratHte Commerce (recetved]: o No Inlorstllte Commerce (9hlppoo): ~ Yes 0 No If you, % 100%
Rolatod Flrm(s)/Locntlol1(s):
MOdlool 0''''''00 MnllufAclLlI!nlj In"III'Ic:III..111 Rupt)lt (ltOIi C\/I?I
McrJical Device lnspeclion Report f-"irm: Big John Producta, Inc.
rone 2 of 10 License Number: 70~ 17
INSPECTION OVmVIEW
On January 5, 20'16, an assiqnment was received 10 conduct an investigation at Big John Products, Inc.
regarding the firm marketing the medical device, Heirnlicll Helper. The assignment indica led thai the
Heimlich Helper is a Class II, 5101( exempt medical device ancl falls under 2'\CFR 868.51'\ 5, devlce to
relieve acute upper airway obstruction. It was noted that the firm (;'Illcldevice are not rG9ister~)cIwith the U.S.
Food end Drug Administration (FDA). It was also noted 111althe firm is not licensed as a medical device
manufacturer with the California Department of Public Health. Fooel ano Drug Branch.
On February 17, 201(), Fooel anel Drug Branch (FOB) Investigator Oesterle tookeo up Ihe regulation 21CFR
868.5115, Device 10 relieve acute upper airway obstruction. See Exhibit 1 and the product classification for
Heimlich Maneuver Assist Device S0!.') Exhibit 2 on the U.S. FDA website. 21CFR 86[3.5'1'15 identifies tl1e
device as a raised, rounded pad that, in the event of choking on a foreign bo(Jy, can be applied to the
abdomen and pushed upward to generate expulsion pressure 10 remove the obstruction to relieve acute
upper alr obstruction. The device is classltier] as a Class II device thM is exempt from the prernarket
notification procedures and js .,over the counter. A search was also conducted for Big John Products and no
results were found See Exhibh 3. A search woe conducted on Ii.e lirrn's website ~.bi~lj.9..b.!JRLq_Q~K\~,Com
and it was observed that the firm was advertising (or sale tile Heimlicl) Helper See Exhibit 4.
On February '18, 2016, food and Drug Branch (FDB) Investigator Oesterle went 10 Big John Producls, Inc.
to verify whether they were l11anufactLlring medical devices, Heimlich Helper, without a valid license front
the California Department of Public Health, Fooe! and Drug Branch and whether lhe firm and device were
fegistered Wit!1 the U.S. FDA. Investigalor Oesterle took a picture of th(1 front of the business See Exhibit
6. FOB lnvestioutor Oesterle entered the facilily and identified herself and presentee! her credentials to
Scoll Kramer, President and Secretary. FOB Investigator Oesterle provided Mr. Kramer
with her business card. FOB lnvesllqator Oesterle advisee! thorn 111211 she was at their firm to verify whether
or not the finn is manufacturing the Heimlich Helper and whether tl)8 Heimlich Helper is registered with the
U.S. FDA. They were advised that 1118FOB had determined that the Heimlich Helper was a Class II medical
device that was 5101< exempt and askeel if they were manulaclurino the device. Mr. Kramer stated that they
do not make the device; but have contracted with ..
_ to make the device. Mr. Kramer slated that is an injection molding facility and makes
the device for them. He stated that is their manufacturer, warehouse and fulfillment center.
FOB Investigator Oesterle asked Mr. Kramer if is registerecl with the U.S. FDA and he stated
he didn't think so. FOB Investigator Oesterle asked Mr. Kramer if made anv other' medical
devices and he stated he thinks they only make his device and also 10yS (or other companies. FOB
Investigalor Oesterle asked if the firm (Iesigneel the device and Mr. Kramer stated that the owner of the
design was ... ; 1 Mr. Kramer stateel that Big
John Products, Inc. paid (or the right of Ihe desiqn and signed an agreement willl •••••••••
thai granted them exclusive license to sell, manufacture and distribute the licensed invention (Heimlich
Helper). FOB Investigator Oesterle asked if 1M Heimlich Helper was registered with the U.S. FDA ancl •.
a I' staled that they spoke 10 the U.S. FO/\ in 201'1 before deciding to obtain the righls 10 sell the
device and thai the U.S. FDA lold 1I1em lhal the device W(lS a Class II device bul thai they were exempt
from premarkel notificalion ano cfidn'l need to register FDB lnvestiqalor Oesterle advised •.
that the device is S10K exempt, but it is not exempt froml')eing reqistered and listed with the U.S. FDA.
! F.e.
MIlII«(,,1 Oavie., M,\II\tl""III(iflllln:ireCUflll ROllOl1 (ltcv a "111
Medioni Devloe lnepecuon R(lpor\ Finn: Big John Products, lno.
Page 3 of 10 License Number: 78417
.... staled that when they tolel him he was exempt he thought It meant the device didn't need to be
reglster'ed wltl, the U.S. FDA.
FDB Investigator Oesterle asked niem who they sell the devices to and Mr. Kramer stated that the Heimlich
I-Ielper iG sold through catalog stores lil(6. €II1CJ e
FOB lnvestlpatcr Oesterle asked Mr.
Kramer If he had any Invoices 10 show that lIl0.y ar(.) wholesaling and he provided an Invoice from _
7•• '
r. datecl2/1DI2016 sso Exhibit 6. FOB Invesllgator Oesterle Elsf<ed Mr. I<rarner who Is responsible
for handling the complalnts from' the customers and he stated that Big John Products, Inc, handles any
complaint regarding lhe device, FOB Investigator Oesterle asked Mr. Kramer If they had received any
complaints regarding the device and he stated that they have not received any complaints Of returns
regarding the device.
Mr. Kramer was advised that it appears that the firm may 1)6 a specification developer and would be
required to apply for a Medical Device Manufacturing License with the California Department of Public
Health as well as register tl1G Heimlich Helper with the U.S. FDA, FOB tnvestigator Oesterle advised Mr.
Kramer that she would discuss Wi(i1 FDB supervision and verify If the firm ie considered a specification
developer and required to obtain a Medical Device Manufacturing License. FOB Investigator Oesterle asked
Mr. I<ramer If the firm had any policies and procedures and he stated no.
FOB tnvestigator Oesterle asked if the firm had any Heimlich Helpers on site and they stated there were
seven on site. !VIr. Kramer stated that the devices are normally shipped from .. to the customer
and tl)at the seven they have 01'\ slte they use to show at trade shows. Mr, Kramer took F'DB Investigator
Oesterle to the storage area and observed that there were seven Heimlich Helpers on site, FOB
Investigator Oesterle took pictures of lhe device and label Sec Exhlblt 7. FOB Investigator Oesterle
observed tl1at the label did nol contain the required name and place of business of 1110manufacturer,
packer or distributor. FDB lnvestiqator Oesterle advised Mr. Kramer and I 2.111$ that the label is
missing the required name and place of business of the manufactural', packer or distributor and Is
consldered misbranded. FOB Investigator Oesterle contacted FOB Supervising Investigator Donna Daily
and advised her that the tim! had 7 Heimlich Helpers on site and that they were misbranded in that the
labels were missing tile required name and place of' bualness tor the manufacturer, packer or distributo;:.' .
She "was also advised 1I1at the device.is, not registered with the U.S, FDA. FDB Supervising Investigator
Dally InstrLlcted FOB Investigator Oesterle to place the 7 Heimlich Helpers under embargo for misbranding
violations. FOB Investigator Oesterie advised Mr. Kramer and. m
P that the Food and Drug Branch
ii
were placing the '1 Heimlich Helpers the firm had on site under' embargo. They were advised that the
Heimlich Helpers would be embarqoed on site and tl1al the firm cannot sell, move or remove the
ernbaraoed devices unless given approval by the Department. FOB Investigator Oesterle provided Mr.
Kramer with a' copy of Article 2 Inspection and Sampling and Article 3 Seizure and Embargo from the
Sherman Food, Drug and Cos.metic Law. Mr. Kramer was advised if the embargoed Heimlich. Helpers were
sold or removed from the Firm without approval from the Department there would be a fine of Lip to $10,000
or up to one year In county jail or both, He was advisee! that that it would be documented on the Embargo
Form.
A total of 7 Heimlich Helpers were ernoarqood for misbranding violations including holding and offering for
sale and receiving in commerce misbranded medical devices whose label failed to bear the required name
and place of business of the manufacturer. packer or dlslrioutor.
ModiuDI nevtce MQllllfaclurill(llnrll1M(IOII "(Ill '),t (ROil 0 1ft 1:1
Medioli\tDevice lnspectlon napoli Firm: Gig John Products, Inc.
Page 4 of 10 Llcense NlIInt))'Jf: 78/117
The wholesale value of the Heimlich Helpers was. 111
The ernbarqood Heimlich Helpers were placed
in a box and lhat box was stored on €I top shetf in the storage area Soo Exhibit 8.
FDB Investigator Oesterle read over the Embargo Notice to Mr. Kramer and he siqned it See Attachment
A. FDB Investig€ltor Oesterle provided a copy of the siqnod Embargo Nolics to Mr. ~<ramer. Mr. Kramer was
advised that the firm would be l'eceiving an Embargo Letter from the Department by mail and the firm would
need to submit a corrective acllon plan regarding the embarqoed devices. Mr. Kramer asked If they could
put an address label with the firm's name and address on the device and FOB Investigator Oesterle
advised (hem that that is considered relabeling which Is a manUfacturing process and the firm would need
\0 be licensecl as a manufacturer. m
r asked If the finn could destroy the covtcss and FDB
1;
lnvestiqator Oesterle advised him that if the firm wanted to voluntarily condemn and destroy (VC&O) the
embargoed devices then they would need 10 submit how they plan on destroying the devices In a corrective
action plan and that it would have to be approved by FDB Supervisillg Investiga(or Daily.
On February 22, 2016, the firm was issuecl a '12 Item Notice of Violation.
1. The firm faile~ to have a valid medical device rnanuracturinq license from the department while
manufacturing medical devices. Specifically, the firm was rnanutacturinq the Heimlich Helper without
a license from the department since 20'12.
2. The flrrn was unlawfully manufacturing misbranded medical devices. Specifically, the firm was
manufacturing the Hflimlich Helpor In an establishment not duly llcensed with the department.
3. The firm unlawfully held and offered for sale misbranded medical devices. At the time of the
Investigation, tt)S finn was holding and offering for sale Heimlich Helpers and was unable to provide
documentation that they had been manufactured in an establishment duly registered with the
Secretary of Health, Education and Welfare of the United States,
4. The firm unlawfully held and offered for sale misbranded medical devices. At the time of tile
investigation, the firm was observed holding and off'ering for sale the following, Heimlich Helper,
medical devices, whose labels failed to bear the required name and/or place of business of the
manufacturer, packer or distributor on the label:
a) '1 units of Heimlich Helpers, Item it 9'11 HI-!
5. TI')e firm unl.,wfully received In commerce medical devices thai are misbranded. AI tile time of the
investigation, lhe followin&1 medical devices whose IQbGis did not contain the required name and/or
place of business for tile manufacturer, packer or distributor:
<I) 7 units of Heimlich Helpers, ltom # 9'11 HH
6: The firm failed to establish procedures to ensure that all purchased or otherwlse received product
and services conform to specified requirements. Specifically, the firm has not established
purchasing control procedures that ensure: (1) requlrements that musl be met by supp.II~r.:
contractors, and consultants are established and maintained; (2) potential suppliers, contractors and
····.·1....
Mot.cal Oovlcu IAlSllulnOhtrlnu lunpncUnn (l.0PQrIIRo</ O'I/tlt
Medical Device tnspectlon Report Firm: Big John Producta, Inc.
Page 6 of 10 License Number: 70417
consultants are evaluated and selected based Oil their ability to meet specified requirements; (3) the
evaluation of potential suppliers, contractors and consultants is documented; (4) the type and extent
of control of the product, services, suppliers, contractors and consultants Is defined; (5) records of
acceptable suppliers, contractors and consultants are established and maintained; (6) purchasing
data that clearly describe or reference product and servtces are established, maintained and
approved,
7. The firm failed to establish adequate records of acceptable suppliers and contraclors.
8, The firm failed to establish adequate procedures for receiving, reviewing and evaluating complaints
by a formally designated unit. Specificatly, the firm has not established complaint handling
procedures that ensure: (1) complaints are processed In B uniform and timely manner; (2) oral
complaints are documented upon receipt: and (3) complaints are evaluated for MDR reportabllity.
g, The firm failed to establish adequate procedures for corrective and preventive action. Specifically
the firm has not established correclive and preventive action procedures that ensure: (1) analyzing
quality data to identify existing and potential causes of nonconforming product or other quality
problems, using appropriate statistical methodology, wilere necessary; (2) investigating the cause of
nonconformltles; (3) Identifying actions needed to correct and prevent recurrence of nonconforming
product and other quality problems; (4) velifylng and validating correcnvs and preventive actions; (5)
implementing and recording changes necessary to correct or prevent identified quality problems; (6)
dlseemlnatlnq information related to quality problems and nonconforming product: and (7)
submitting relevant information for management review.
'10, The firm failed to establisll adequate procedures for training and identifying training needs.
Speoifloally, the finn has not established personnel trainin9 procedures that ensure: (1) all personnel
are trained to adequately perform their assigned responsibilities.
1'1. The firm failed to document personnel training. Speciflcally, the firm failed to provide documentation
that personnel have been adequately trained to perform their asslqned responsibilities,
12. The firm failed to establish adequate procedures to controllabeting activities. Specifically, the
procedures to conlrollabeling activities InLISI assure: (1) labels are printed and applied so as to
remain legible and affixed during processing, storage, handling, distribution and/or Use; and (2)
labeling has been examined for accuracy for a designated individual prior to storage or lise and the
. release of labelino in appropriately documented.
On February 23, 20·t6, a search W21S conducted on the U,S. FDA website for' 'I It II see
Exhibit 9 "Heimlich Helper" See Exhibit 1 0, "8i~J john Products Inc." See Exhibit 11 and "a.12.I:_"
Sea Exhibit 12 and no results were found,
On February 23, 2016, the firm submitted their corrective action plan to voluntarily destroy the embargoed
Heimlich Helpers. The corrective action plan also stated thElI they are suspending all sales of the device
until or unless they can SUb-license the product to an FDA reqisiered manufacturer See Exhibit 13,
Modlc.1 00 vic. M.n~l.cltl(lnn Ino"o"loOl ROPQrI(Rov01/\21
Medlo,ll Devloe Inspection Report Firm: Big John Products, Inc.
Page 6 of 10 License Number: 70417
On February 24, 20'16, FOB Supervising Investigator Daily contacted the firm by email and asked them how
they plan on destroying the Heimlich Helpers. Sh(') also advised them that the device would need to be
removed from their website 8S one of the products they are offering for sale.
On February 25, 2016, Mr. Kramer reptled tha: the Heimlich Helpers would be destroyed by being cut In
half with a saw and disposed of in the trash and that the Heimlich Helper would be removed from their
website by the and of the week, FOB Supelvislng Investigator Daily approved the>tlrm's plan to VC&D the
embargoed Heimlich Helpers by cLitting them in half and disposing of them in the trash. FOB Supervising
Investigator Dally notified FDB Investigator Oesterle that the finn's corrective action plan had been
approved. FOI3 Investigator Oesterle contacted Mr. Kramer and the VC&D of the embargoed Heimlich
Helpers was scheduled for February 29, 2016. .
On February 29, 20'16, FOB Investigator Oesterle went 10 the firm to witness tile VC&O of the seven
Heimlich Helpers that were embargoed on February 18, 2016. FOB Investigator Oesterle read over the
Embargo Release form and Mr. Kramer signed it See Attachment C FOB Investigator Oesterle provided
Mr. Kramer with a copy of the Embargo Release fO(ITl. FOB Inv6stlgotor Oeslerle read over Voluntary
Condemnation and DestrLlction (VC&O) form and Mr. I<ramer signed it See Attachment O. FDB
Investigator Oesterle provided Mr. Kramer with a copy of the VC&D form.
FOB lnvestlqator Oesterle then observed. r] _
remove the box containing the seven Heimlich
Helpers' from the top shelf and place it on the edge of a trash call See Exhibit 14. FOB Investigator
.Oesterle witness _nEll.
remove U1e Heimlich Helpers from the box, cut them in half with a saw and
dispose of the pieces in the trash can See Exhibit 15. FOB lnvestiqalor Oesterle searched the firm's
website and observed that the Holmlich Helper hac! been removed from the site See Exhibit 1G.
An embargo letter was mailed to the firm.
HISTORY OF FIRM
The firm was has not been previously inspected by the U.S. FDA or the State.
PROOUCTS
The firm is a specification developer of the Heimlich Helper which is ~I Class II, 51 OK exempt medical
devices under 21 CFH B(lll.5115. The device is non-sterile and sole! wholesale to cataloq stores. The
Heimlich Helper was cesloned by • .:oeated in New York and Big John Products Inc. paid for
the exclusive license to sell, manufacture and distribute the device. The Hoimllcn Helper is rnanutacfured
by" • 2 7 ~b • b •.
.P!;RS.ONNEL Q._UAUFICATIONS
• Scott Kramer " Presidenl
•• • : l -Secretary
The firm's operations consist of specification development. Mnn8gement controls 1811 under the
responsibility of the manufacturer 01 the device. Management Review and lnternal Audit procedures were
identified to not be required from the firm.
ModiMIl)oYloo MnnutnolUrln{l h\!poclllln IlcJlMI (nOY 011(2)
Medical Devlce Inspection Report Firm: Big John Procluolll, 1110.
Puge 7 of 10 License NlIrnb(:)/,: 70417
TI16 firm has not established a quality system. It was deterrnineo that the firm needed toestaol'sh policies
and procedures for labeling, purchasing controls, complaint I~anclling, CAPA "HId training.
FDB investlqator Oesterle asked Mr. Kramer if the firm had established procedures for the training of
)01'60n1'161 Md Mr. Kramer stateo he did not have any pollcies for personnel training because he didn't
1<now he was considered a manufacturer of the devlce. Mr. Kramer was asked If the firm had personoel
tralnlt'lg records and he stat(~d no.
1. The firm failed to establish adequate procedures for training and Identifying training needs.
Specifically, the firm has not established personnel training procedures (hat ensure: (1) all personnel
are trained to adequately perform their assignee! responslbllltles.
2. TI1e finn failed to document personnel training. Specifically, the firm failed to provide documentation
that personnst have been adequately trained 10 perform their assigned responsibilities .
.EAC..l.b.ll'!
The firm is located in a one story building in suite 0 that is approximately 1600 sq. ft. The firm holds the
business hours of Monday through Friday 1000 to '1600.
EQUIPMENT
The firri1 does not perform any manufacturing activities on site.
RAW MATERIALS
The firm has contracted wltn ••••• located at •. 7 Fl.
manufacture, store and ship the devices to the customer. FOB Investigator Oesterle asked Mr. Kramer if
.11._.-
to
the finn had established policies and procedures for purchasing controls and he stated no. FDB
Investigator Oesterle asked Mr. Kramer if he evaluated his suppliers and he stated that he did visit"
•• S. prior 10 contracting willl them to manufacture the device. Mr. Kramer was asked if the flrm has an
approved supplier list and he staled no. Mr. I<ramer was advised Ihat the firm needed to establish
procedures for evaluating suppliers, contractors or consultants and 10 document U1eevaluations.
1. The firm tailed to establish procedures to ensure that ali purchased or otherwlse received
product and services conform to specified requirements. Specifically, lhe firm has not
established purchasing control procedures that ensure: (1) requirements that must be met by
supplier, contractors, and consultants are established and maintained; (2) potential suppliers,
contractors and consultants are evaluated and selected baaed on their ablllty to meet specified
requirements: (3) the evaluation of potential suppliers, contractors and consultants is
documented; (4) the type ,mel extent of control of the product, services, suppliers, contractors
and consultants is defined; (5) records of acceptable suppliers, contractors and consultants are
established and maintained; (6) purchasing data thai clearly describe or reference product and
services are established, maintained and approved.
2.. The firm failed to estaolieh adequate records of acceptable suppllers and contractors
The firm's main suppliers are:
Mddlr.OI Oovh;Q MClluti\CHU'ln{l lIuf)ocUnu RIlPOl1 (R.ev 1)1(12)
IY10cJlcaiDevloe mspectlcn Report Firm: Big John Products, Inc,
Page 8 of 10 ttcense Number: 71J417
.11 dU (contract manufacturer for the Heimlich Helper)
&. -
• • (iabels)
• E
The firm does not receive any finished devices. The finislled devices are shipped from the contraot
manufacturer direc(!y to the customer.
MANUFACTURING PROCESS & CONTROLS
TI)e finn does not manufacture or distribute (lie device, The Heimlich Helper is manufactured and shipped
by the contract manufacturer, SV • The firm does nol store or dlstrloute the Heimlich Helpers from
their location, The seven Heimlich Helpers that were observed on site were used for trade al10WS according
to Mr, Kramer. Mr. Kramer was asked if the finn hael established procedures for non-contormancee,
complaint handling and corrective and preventive action (CAPA) and lie stated no. Mr. Kramer was asked If
the firm was responsible for handling customer complaints and he slated yes, MI:' Kramer was asked If lhe
lirm has received any customer complaints and he stated no. Mr. 'Kramer was asked if the firm had any
CAPAs and he staled no. Mr, Kramer was asked If the firm has had any Heimlich Helpers returned to them
by the customer and he stated no, He stated that any returned product would go back to the retailer who
sold the product to the customer. Mr, Kramer sated that he has never received any complaints of non-
conformance of the product or instances of where the customer was hurt by using the product. FOB
Investigator Oesterle advised Mr. Kramer that the firm would need to establish procedures for complaint
handling and CAPA.
'1. The firm failed to establish adequate procedures for receiving, reviewing and evaluating
complaints by a tormauv designated unit. Specifically, the firm has not established complaint
handling procedures th::lt ensure: (1) complaints are processed In a uniform and timely manner;
(2) oral cornplalnts are documented upon receipt: and (3) complaints are evaluated for MDR
reporlabiiity.
2. The firm failed to establish adequate procedures for corrective and preventive action.
Specificelly Ihe firm has not established corrective and preventive action procedures lhat
ensure: (1) analyzing qualily data to identify existing and potential causes of nonconforming
product or other qLlality problema, lIsing appropriate statlstlcal methodology, where necessary;
(2) Investigating the cause of nonconformities: (3) idenlifying actions needed to correct and
prevent recurrence of nonconforming product and other quality problems; (4) verifying and
vl:llkialing corrective and preventive actions; (5) Implementing and recording changes
necessary to correct or prevent identified quality problems; (6) disseminating information
related to quality problems anu nonconforming product; and (7) submitting relevant intortnaffcn
tor management review.
LABELING
The firm did not nave establlshed policies and procedures for labellnq activities. Mr'. Krarner was asked 'N.t)\)
was responsible for the labeling of the device and he stated lhe finn has contracted with In: \0 -.
print the label anci send it to~III?"' .~. to attach to lhe device Mr, KI'amer was asked who d\~slgn13q \h~
Medical Device mspection Report Firm: 81g John Products, Inc,
Pf.\ga 9 of 10 License Number: 78417
label and he staled that he designed the 1&1I)elfor the device, FDD lnvesliqator Oesterle asked Mr. Kramer If
the firm had a master record of the label and clocumentation thai IhB current label being used was
approved and he slotted no, Mr, kramer was advised lhelt the firm would nesd to establlsh procedures for
labeling anci maintain documentation that the label being used on the device has been approved for use by
a cieslgnatecl individual.
1, The firm failed to establlsh adequate procedures to control labeling aoilvltlea. Specifically, the
procedures to control labeling activities must assure: (1) labels are printed and applied so as to
remain legible and affixed during processinq, storaqe, handling, distribution and/or Use; and (2)
labeling has been examined for accuracy for a desiqnated individual prior to storage or use and
the release of 1<lbeling in appropriately documented,
8.Q_TlQ!i§
12 Item Notice of Vlolatlon lssued
MANAG§MSNIDISCW..Q.lli_ON
On February 22,20'16, the Notice of Violation was discussed with Mr. Kramer anct . Mr,
Kramer signed the Notice of Violation and was provided a copy. FOB Investigator Oesterle advised Mr,
Kramer lhat if lIle firm wants to continue manufacturing the device they would need to submit an application
for a New Medical Device Manufacturing License to tile California Department of Public Health, Food and
Drug Branch as soon CIS possible and register the device with the U,S. FDA. Mr Kramerwas advised to
submit a corrective action plan for the ernbarqoed Heimlich Helpers directly to FDB Supervising Investigator
Oaily. Me. Kramer was advised to submit a corrective actlon plan along with the missing procedures and
records for the Items noted the Notice of Violation directly to this investigator, Mr. Kramer stated thaI is was
his intention not to manufacture or sell the device anymore. Mr. Kramer was advised to put whatever
decision the finn decides to make regarding the Heimlich Helper in a corrective action plan and submit for
approvnl.
ru;CQMMENDATION§
Recommend no further actlon indicated
ATTACHMENTS
A. Embargo Notice
B, Notice of Violation
C, Embargo Release
D, VC&D
EXHJ.Iill~
1,21 CFR 868,51 '15, Device to relieve acute upper airway obstruction
2, Product Classification for Heimlich Maneuver Assist Device
Moeno.' Oovloo M""u'ncuor'nu k.npocUlln nop.e' (IIev ""121
Medical Device Inspection Report Firm: f3iy John Pronuct«, Inc.
Page 100110 Ucense Number: '{O~'17
3. U.S. FDA Establishment Hegistration & Device Listing for "8ig .John Products Inc."
4. Big .John Products Inc. Website Advertisement showing the Heimlich Helper
5. Photoqraph of Front of Firm
6. Invoice from ••••• "
7. Photcqraphs of the Heimlich Helper and Label
8. Pnctoqraphs of Embargoed Heimlich Helpers
9. U.S. FDA Establishment Registration and Listing for 'I' ••••••
10. U.S. FDf\ Establishment Registration and Lisling (or "Heimlich Helper"
11. U.S. FDA EstGiblishment Registration and Lisling for "Bi~JJohn Products Inc."
12. U,S. FDA Establishment Registration and Lisling for "'......
13. Corrective Action Plan
14. Photographs 01 Embargoed Heimlich Helpers
15. Photographs of Destroyed Heimlich Helpers
16. Big John Products Inc. Website with Heimlich Helper Removed
Investigator's Nama: Diane Oesterle Ba<lgo No. 177
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SCientist's Roview/Commonts:
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scionusrs SlfJfloturo: Outo:
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ENitlAI~GO NOTICE
1-00(1 and DrlJSI Branch
in the possession QI 8533 Canooa~:J_"._Ave.,,_ •. _.,Suite
w. ._,._ _.. ,_._ D, Canooa
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Owner (if cliHerent)
You are 11ereby nolifi8cl that the lollowing materiats have been ernbarqoed tly tnis Departmenl on tile above date under tile
provisions of California Health and Safely CO(10, Division '104. Chapter n, Article 3, Section 111060.
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QUANTITY SIZE OF UNITS MATERIAL I.S. NUMBER
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7 each
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Heimlich
_ _ _--_
Helper. Item /I. 911 HI-!
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WARNING: tt is IIll/awful for ilIly perso« 10 rCIIIOVI}, 5ull, or dispose of ttits III;rleriiJ/ WllliOllr ncrmts ston of th« Food "'1(1 fJrrrg
BrRllcil or of OHJ court, vtoteuo» of tlsls ortter is il IlIis((CIIlIIilIIO(,
irl~f)stHI.\~;0i;n'Tt;:;(j9·C ";~';1'(l~;". ------.- ..--.--
l Diane Oeste: I(~ 1/ .\ n .-. - .__ .... --_ ... - ..
El'g John Products: Inc
Cn1lifJ1IUII ()i,ljlilIIIIlCI\\ 01 1'lrilUr. Hllfllll\
NOTICE OF VIOLATION
Food clnclDrug Hranch
Tile conditions or practices noted below were observed 011 suujm:t premises tllis <lal(·!. These are nllr.gerl 10 1)0 vlotatlons of
one or more provisions of California law pell8ininn 10 tile manutacture. processlnq, holding, sale, 111I)oling, or advertlstnq of a
iooo. drug, medical device, cosmetic. or hazardous substance. Tile Departmenl may seek adruinlslrative, civil, or crirninal
action (or each of the viola lions. This report has been prepared to alert the management of tile investigator's findings. It is
the responsibility of the finn to assure comptiance witll all applicable taws and regulations
_ __ .._------ _ -._-_.-._ __ __ .._-_._._-_ .. __ _._----
_ ..
1, The firm failed to have a valid medical device manutactunnq license Irorn the department wllile
manufacluring medical devices Specifically. the Iirrn was manulactunnq ihe Heimlich Helper
withoul fl license from the department since :?O12.
2. The finn was unlawfully manufacturing misbranded medical devices. Specificany, the firm was
man~lf'lcluring tI'18 Heimlich Helper in ail establishment not duly ucenseo with the department.
3. Tile finn ~lnlawfLilly he lei F.Hlli oflerecl for sale misbranded medical devices. At lhe time of the
investigalion, lhe firrn was holding and offering for sc;le Heimlich Helpers ano Wr.1S unable to
provide documentation thai they hac! been manulactured in CHI establishment dulv renislered with the
Secretary of Health, Educalion and Welfare of the United States.
4. The firm unlawlull« held and ortered for sale misbranded medical devices. At the tune
of uie invesligation, the firm was observed IlOlding and offerin9 for sale the following, Heimlich Helper,
medical devices. whose labels failed Lo bear lhe required name and/or place of business of the
manufacturer, packer or oistributcr on tile Icll)cl
a) 7 units ot Heimlicn Helpers, uem U 91'11-11-1
§i9.!. in tllis notice does not i~c1icat£_~~I~si~~~_<!. viot,lli<?~~!._l_Jl~~~y..!~ce.i1?l_~~_tlle.~~.~.~_of vi9.~:l9!,~_,,_.
__ . _
FiU1\' I ,11\01120(1 loproscnilltivc !linntllllf(! ,\u01(Hi7.r.(11f~pl(:~WIlI,'llilJf! pn!\illon
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Diane Oesterle 11 'I n
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r.nlllornlH Dopn"/I,ol'! oll'IIulio Ilonlill
NOTICE OF VIOLATION,Contlntloc1
5. The firm unlawfully received in commerce rnedlcal devices that Hr0 mtsbranded. At the time
of the Invt1al'lgatlon, the following medical devices whose iabela did not contain the required nama
andlor place of business for Ihe manufacturer, packer or clifltril:)utor:
a) 7 units of Heimlich Helpers, Item If. 9111-1H
6, The firm failed to astabllsh procedores to ensure that all purchased or otherwise received product
and services conform to specified requlrements. Specifically, the Iirm has not established pLlrchaslng
control procedures that ensure: (1) requirements that mus: be met by supplier, contractors, and
consultants are established and maintained; (2) potential suppliers, contractors and consultants'
are evaluated and selected based 011 their ability 10 meet apeci'flecl requrernents; (3) the evaluation
of potential suppliers, contractora, and consultants is documented; (4) the type ane! extent of control
over the product, services, suppliers, contractors and consultants is detlned; (5) records of
acceptable suppliers, contractors, and consultants are established end maintatned: and (6)
pLlrctlElslng data that clearly describe or reference product and services are established, maintained
and approved.
7. The firm failed to estabtlah adequate records of acceptable suppllers and contractors.
O. The firm f~lIed to establish adequate procedures for receiving, revIewing and evaluating complaints by a
formally designEl\(!Jd uni!. Specifically, the finn has not established complaint handling procedures that
ensure: (1) complaints are processed In 01 uniform and timely manner: (2) oral complaints are documented
upon recelpt; and (3) complaints are evaluated for MDR reportablhty,
g, The firm failed to establish adequate procedures for corrective and preventive action. Specifically, the
firm has not establiehed corrective and preventive action procedures that ensure: (1) analyzing quality data
to identify existing and potential causes of nonconforming product or other quality problems, \.Ising
approprlate statistical methodology, where necessary; (2) investigating the cause of nonconformities;
(3) Identifying actions needed to correct and prevent recurrence of nonconforming product and oiner
quality problems: (4) verifying and validating corrective and preventive actions: (5) implementing anci
r¢Gording crHlng8$ necessary to correct and prevent idl'lntlfled quality problems; (6) diasemln~tlng
Information related to qu~Hty problems arid nonconformlnq product; and (7) submitting relevant Inforrnatlon
tor manacement review.
'10. The firm failed to establish adequate procedures for training and identifying training needs. Specifically, the
firm has not establlBheo personnel training procedures ttlat ensure: ('I) all personnel are traineel to
adequalely perform their assigned responslbthties.
'11. The firm fa.iled to document personnel tralnlnq. Specifically, the firm foiled 10 provide documentation that
personnel have been adeqcatety trained to perform their assigned responsibilities.
12. The firm failed to establish adequate procedures to control Iabelmq activities, Specifically, procedures
to control labeling activities must 85SLlre: (1) labels are printed and applied so as (0 remain legible and
affixed during processing, storaqe, handling, distribution and/or use; and (2) labeling has been
examined for accuracy by a deSignated individual prior to storage or Lise and the release of labelino
Is appropriately documented.
SU\\o ul C:uUIOrr\ln~#llul\lIh ltlllllh"'~UII\ S()l' viCl\1! "tllIoe.,. (,;111Ih,:uIIIIOI1Ili,qlluJIII(!'f'III11Ir.I-llt!111I1
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EMBAI~GO NOTICE
,)Pq}/I, /It'
Fooci ,lnci DrllO 13r;:ll"1cll
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Ontario (909) 605-6491 02/'1(3/2016
Address ("umbor. STriiiio'--"-"--'" ......-.---- .... --.-.-- - ...-.---.. ...-.- ...- 'c:iiy- ..- .-- ..----------.-- ..-...-- .. - - - "- Iiili:iiiiO· ..--·-·--····-·- .
2'151 Convention Centervvav, 1/·2'1ill3 Ontario 9'1764
--_ .. __ .._ ....... _--_... ....... .. _ _ _._---
..
Owner (if different)
You are hereby notillec that Ihe following materials have been embargoed by this Oopartrnent on tile above dale under (he
provisions or California I-Iealtll ariel Satety Code Division 10/-1. Chapter 8. Miele J. Section 111(l60.
qUANTITY SIZE OF UNITS MATERIAL I.S. NUMBEH
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7 each Heimlich Helper, uem II 9111'11-1 '1770218 t 61-\
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WARNING: /( Is unlnwiu! (or all)' parson (0 mnlOVrJ, sell, or itispos c of this (lliI(~'riill wittiou: nermission of (/ICl Fooel ali(I Owg
/ilrnllcfl or of (ho court. Via/lilian of (Ills ordor is iI rll/s(le(l)I).~n()r .
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Food nud Drug Brliliell
21.51 Convention Center Way, 21 BEl
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Ontario, CA. 917(il.l
J __ 909 ) 605-649 I
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OWN81l
L,OCAT!ON 01" MATKRIAL
Firm nal\1eJ~iR:lo~)J)~:~~I.\I~:lS, [~I~.~ .__ _ .. .. .. _
Addl'0SS Ji.~l.~.~~~!j
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I (We) hereby voluntarily agree COthe condemnation unci destruct ion 01' lhc Collc)Wlllg Illa[CI ia]:
.?_~Ini_l:~_?rl'lel~llich l-lelpel·,. [t(;t~._i!:.~.IJ_I.~~ .. ..__ _._. __. . .._._.._ __ ..
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suid I1llltel'inl being unfit tor human consumption or otherwise ill violation of' the Culifomia Health and Safety Code,
Divisioll lOti, Chapters I through 8, the disposition ofwhich is provided I.'l)!' by Chapter 8, Article 1, Section 111895.
I (W,) hereby: I,,,,, the C"iI rom i" S ,,,te 001'''''''''''' "r I' "hi" '~,"Ill' ':~~~~:::~'~ ,,~~~ ":bd il~ .. __ .. __
»< "-:~Tl\II;l,l\Ifl! (AullIori'f.t.:d 1~~IIIU~l!ll{lIliv<.! ofOwller)
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[)ate, IAH:,I['ioll, 1111(1Metho d of' Dcstructiuu
211.!)/2016- Di!l Johu Prnducts, IIIC., HS:I) Cuncga Avc., Suitt: I), Callog,l 1'III'k, (:/\ ')110'1 ..· Cltll'ing the Heimlich Helpers ill liall' willi a saw
and di~p()~ill~ of them inthe trash. .
WITNI':SS: ()I"FICI~ LOCATION:
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