Jacek Cieslak

FDA Investigator Report

Designation: CHEMIST

Duty Station: Silver Spring MD 20993-0002

Organizations: DHHS FDA CDER OMPT CDER OPQ OBP DBRRIV

Total Inspections: 12

Total 483s Issued: 10

Total Warning Letters Issued: 0

Inspection Details

Longest Inspection: 12 days

Shortest Inspection: 2 days

Average Length of Inspection: 8.0 days

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Recent Inspections

DateCompanyCityCountryFEI Number483
2024-01-30AbbVie Bioresearch CenterWorcesterUnited States3003684386
2023-09-01Samsung Biologics Co., Ltd.YeonsuKorea (the Republic of)3010479596
2023-01-24Alexion Pharma International Operations Unlimited Co.Dublin 15Ireland3012889718
2022-06-10Pfizer Inc.BothellUnited States3002781621
2022-03-25Formycon AgPlaneggGermany3010190542
2022-03-22Polpharma Biologics S.AGdanskPoland3013195136
2021-08-30Kyowa Hakko Kirin Co., Ltd.TakasakiJapan3007588904
2021-08-30Kyowa Hakko Kirin Co., Ltd.TakasakiJapan3007588904
2021-08-23Chugai Pharma Manufacturing Co. Ltd. (CPMC)KitaJapan3004109596
2021-04-21FujiFilm Diosynth Biotechnologies U.S.A., Inc.Research Triangle ParkUnited States3000718852

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Download 483s and EIRs for Jacek Cieslak

Co-Inspectors

NameInspectionsLast Inspection
Zhong Li42023
Michael Shanks32022
Hamet M Toure12024
Hyung-Yul Lee12023
Dogbeda F Mackenzie12023
Wayne E Seifert12023
Jeffrey P Raimondi12023
Wendy G Tan12022
Christopher R Czajka12022
Matthew B Casale12022
Michael A Charles12022
Yun Wu12021
Zhihao Pete Qiu12021
Seneca D Toms12021
Richard Ledwidge12018
Ashar P Parikh12018

Active Locations

Year-wise Inspection Count