Beruflich Dokumente
Kultur Dokumente
17-15217
Madhuri Trivedi vs. U.S. DEPARTMENT OF HOMELAND SECURITY, John F. Kelly, in his
Official Capacity as Secretary of Homeland Security, U.S. CITIZENSHIP AND
IMMIGRATION SERVICES, Lori Scialabba in her Official Capacity as Director- U.S.
Citizenship and Immigration Services,
Donald Neufeld -director USCIS service center in his individual capacity,
Greggory Richardson- director TSC - in his individual capacity,
Mark Hazuda- Director NSC - in his individual capacity,
John Roth, OIG - in his individual capacity,
Maria Odom-DHS- in her individual capacity
_________________________________________________________________
Appellant MADHURI TRIVEDI March 4th 2017
Exhibit 3..all 600 defects were closed in one day without doing anything during
last few months I was there..GE argument was that they will be addressed/closed when
existing product is replaced with new product. But when defects were closed there was
no new product in existence. And GE was replacing back office software and not medical
device software. Replacing medical device software on 100,000 devices requires
RECALL from GE or FDA.
In 2007, GE Healthcare entered a consent decree with the FDA which prohibited
the manufacture or distribution of surgery OEC C arms medical imaging devices
(
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2007/ucm108
828.htm) . Ms. Trivedis first project for GE Healthcare was to work on finally
bringing a related product back to market. Being aware of the checkered history, I
was putting highest standards; but was punished for following quality processes.
18) Insite Production issue screen
Appellant
MADHURI TRIVEDI
P.O. Box 8359
Fremont, CA 94537
Madhuri.orangehc@gmail.com
Phone: 650-242-5135
Fax: 708-774-4859
March 4th 2017
CERTIFICATE OF SERVICE
I hereby certify that on this date, I caused a true and correct copy of this statement
delivered electronically to Gisela Westwater.