DEPART!

\fi: NT OF HEALTH AND H UMAi' l SERVICES

FOOD AND DRUG ADMINISTRATION

D ISTRICT ADDRESS AND PHONE NUMBER

DATE(S) OF INSPECTION

158- 15 Liberty Avenue

Jamaica, NY 11 433
(7 18) 340 - 7000 Ext: 5301 Fax : (7 18)662- 5661

1/26/ 2016 - 1/29/ 2016*

FEJNUMBER

3003684822

NAME AND TITLE OF INDM OUAL TO WHOM REPORT ISSUED

Dr . Robert J . Panser
F IRM NAME

'

Chief Quality Officer

STREET ADDRE SS

University Of Rochester Medi cal Center

601 Elmwood Ave, Box 608

C ITY. STATE. ZIP CODE. COUfflRY

TYPE ESTABLISHMENT INSPECTED

Rochester, NY 1 4642 - 0001

Hospital

This docwuent lists observations made by the FDA representative(s) dwmg the inspection of your facility. They are inspectional
observations, and do not represent a final Agency determination regarding your compliance. If you have an objection regarding an
observation, or have implemented, or plan to implement, conective action in response to an observation, you may discuss the objection or
action w-ith the FDA representative{s) dwmg the inspection or submit this infonuation to FDA at the address above. If you have any
questions, please contact FDA at the phone munber and address above.

The observations noted in this Form FDA-483 are not an exhaustive listing ofobjectionable conditions. Under the law, your
firm is responsible for conducting internal self-audits to identify and c01nct any and all violations ofthe quality system
requirements.

DURING AN INSPECTION OF YOUR FIRM I OBSERVED:

OBSERVATION 1
The written MDR procedure does not include documentation and recordkeeping requirements for
systems that ensure access to infonnation that facilitates timely follow-up and inspection by FDA.
Specifically, your MDR procedures for collection of inf01mation to dete1mine if an event is reportable
includes an intemal incident rep01i ing and risk management application system, along with concunent
and retrospective reviews . Events reviewed lmder this inspection were found to be incomplete; for
example there was no contact with Clinical Engineering for event numbers 0{6 [0{6 , and (6 . A user
enor for an incident that occmTed on 5/16115 under event number[b\~1] was still 1sted as an
equipment enor, and event #f6{61l that occmTed on 3{611
involved an ankle tag, and event i bf6JI
found that the equipment necessaty for review had not been sequestered.
Specifically, your MDR rep01iable event files are listed lmder the N ew York State Department of Health
I andf0{3Y
1.
(NYPORTS), detail code 938 with occmTence ID numbers f6{3)

Obsetvation 1:

Annotations to Observations
Promised to conect

*DATES OF INSPECTION

1/26/2016(Tue), 1127/20 16(Wed), 1/29/20 16(Fri)

EMPLOYEE(S) SIGNATURE

SEE REVERSE
OF THIS PAGE

DATE ISSUED

Harry J Brewer, Investigator

JmoaklsQI"'Mure

1/29/2016

X Hany J B<ewer

--"

HIIJY l . _ ,
Slgnedi: Hwr( J. Ift.e" ~

FORM FDA 483 (09/08)

PREVIOUS EDmON OBSOLEJE

INSPECTIONAL OBSERVATIONS

PAGE I OF2 PAGES

DEPART!\fi: NT OF HEALTH AND H UMAi' l SERVICES

FOOD AND DRUG ADMINISTRATION

DATE(S) OF INSPECTION

D ISTRICT ADDRESS AND PHONE NUMBER

1 58 - 1 5 Libert y Avenue
Jamaica, NY 11 4 33
(7 1 8) 3 4 0 - 7000 Ex t: 5301 Fax : (7 1 8)662 - 5661

1 /26/20 1 6 - 1 /29/20 1 6*
FEJNUMBER

300368 4 822

NAME AND TITLE OF INDM OUAL TO WHOM REPORT ISSUED

Dr . Robert J . Panser , Chief Qu alit y Officer

F IRM NAME

STREET ADDRESS

Universit y Of Roches t er Medi cal Cen t er

60 1 Elmwood Ave, Box 608

C ITY. STATE. ZIP CODE. COUfflRY

TYPE ESTABLISHMENT INSPECTED

Roches t er, NY 1 4 6 4 2 - 000 1

Hospit al

EMPLOYEE(S) SIGNATURE

SEE REVERSE
OF THIS PAGE

FORM FDA 483 (09/08)

DATE ISSUED

Harry J Brewer, I nvest igat or

1 /29/20 1 6

X Hany J B<ewer

PREVIOUS EDmON OBSOLEJE

INSPECTIONAL OBSERVATIONS

PAGE20F2PAGES

The observations of objectionable conditions and practices listed on the front of this form
are reported:
1. Pursuant to Section 704(b) of the Federal Food, Drug and Cosmetic Act, or
2. To assist firms inspected in complying with the Acts and regulations enforced by the
Food and Drug Administration.

Section 704(b) of the Federal Food, Drug, and Cosmetic Act (21 USC 374(b)) provides:
"Upon completion of any such inspection of a factory, warehouse, consulting
laboratory, or other establishment, and prior to leaving the premises, the officer or
employee making the inspection shall give to the owner, operator, or agent in charge a
report in writing setting forth any conditions or practices observed by him which, in his
judgment, indicate that any food, drug, device, or cosmetic in such establishment (1)
consists in whole or in part of any filthy, putrid, or decomposed substance, or (2) has
been prepared, packed, or held under insanitary conditions whereby it may have become
contaminated with filth, or whereby it may have been rendered injurious to health. A copy
of such report shall be sent promptly to the Secretary."