Amy M Cramer

FDA Investigator Report

Designation: CONSUMER SAFETY OFFICER

Duty Station: East Brunswick NJ 08816

Organizations: DHHS FDA ORA OGROP ORA OMPTO OMDRHO DMDRHOI MDRHCB

Total Inspections: 197

Total 483s Issued: 96

Total Warning Letters Issued: 9

Inspection Details

Longest Inspection: 43 days

Shortest Inspection: 1 days

Average Length of Inspection: 2.4 days

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Recent Inspections

DateCompanyCityCountryFEI Number483
2018-08-01KasiosL UnionFrance3005112488
2018-07-26Supersonic Imagine, SAAix En Provence Cedex 3France3007253513
2018-07-19Veryan Medical Ltd.GalwayIreland3011632150
2018-06-29Nano-Ditech CorporationCranburyUnited States3005174594
2018-05-23Sivantos, Inc.PiscatawayUnited States2217809
2018-05-04Swissray International Inc.EdisonUnited States3000718029
2018-04-24Hamamatsu CorporationBridgewaterUnited States1000121818
2018-04-17EDDA Technology, Inc.PrincetonUnited States3004857110
2018-04-06Amneal Pharmaceuticals, LLCPiscatawayUnited States3008861605
2018-03-01Isomedix Operations Inc.South PlainfieldUnited States2246552

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Download 483s and EIRs for Amy M Cramer

Co-Inspectors

NameInspectionsLast Inspection
Doreen P Gubbay52011
Kristen E Rescigno42010
Meredith L Sheridan42010
Edward Oshaughnessy32011
Lauren L Vajo32011
Kinh Q Mac32010
Addam S Reynolds22012
Barbara J Wilimczyk-Macri22012
Nicholas A Violand22012
Joy R Klena22008
Justine Tomasso22008
William R Chang12018
Yvesna C Blaise12018
David H Smith12013
Dennis E Guilfoyle12012
Erin D Mccaffery12012
Kelli F Dobilas12012
Atul Agrawal12011
Jose M Cayuela12011
Jennifer Macmillan12010
Dhaval H Patel12010
Frederick Razzaghi12010
Michelle M Parisi12009
Hitesh R Patel12009
Byungja E Marciante12008
Marcelo O Mangalindan12008

Active Locations

Year-wise Inspection Count