Monika Borkowska

FDA Investigator Report

Designation: CONSUMER SAFETY OFFICER

Duty Station: Parsippany NJ 07054

Organizations: DHHS FDA ORA OGROP ORA OMPTO OPQO DPQOI PQIBI

Total Inspections: 27

Total 483s Issued: 13

Total Warning Letters Issued: 2

Inspection Details

Longest Inspection: 49 days

Shortest Inspection: 2 days

Average Length of Inspection: 13.4 days

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Recent Inspections

DateCompanyCityCountryFEI Number483
2023-01-20SOFIE Co. dba SOFIESomersetUnited States3005705951
2022-11-23Quinta-Analytica s.r.o. - Provozovna BrnoBrno-Reckovice A Mokra HoraCzech Republic3019851307
2022-11-18Lek PharmaceuticalsLjubljanaSlovenia3002807460
2022-11-11Cambrex Profarmaco Milano SrlPaulloItaly3003723076
2022-09-28Pfizer Inc.ParsippanyUnited States3003836868
2022-08-17Bentley Laboratories LLCEdisonUnited States2244819
2022-07-08KVK Tech, Inc.NewtownUnited States3005117563
2022-05-10Brisar Industries, Inc.PatersonUnited States3003559457
2022-05-03Perritt Laboratories Inc.HightstownUnited States1000122341
2022-03-25US Pharmaceuticals Inc.South PlainfieldUnited States3008275696

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Download 483s and EIRs for Monika Borkowska

Co-Inspectors

NameInspectionsLast Inspection
Yvesna C Blaise42019
Anthony J Donato32022
Guerlain Ulysse22023
Robin P Mathew22022
Amit Kokate22019
Mesfin Abdi22019
Josh Renzo N Ramilo12023
Victoria Spivak12022
Odera I Ekwunife12022
Saleem A Akhtar12022
Jose M Cayuela12022
William R Chang12021
Irina Gaberman12020
Nicholas A Violand12019
Emmanuel J Ramos12019
Helen Verdel12018
Yvins Dezan12018
Melissa T Roy12018

Active Locations

Year-wise Inspection Count