Mindy M Chou

FDA Investigator Report

Designation: Regulatory Officer

Duty Station: White Plains NY 10605

Organizations: DHHS FDA ORA OGROP ORA OMPTO OPQO DPQOI PQIBII

Total Inspections: 104

Total 483s Issued: 84

Total Warning Letters Issued: 7

Inspection Details

Longest Inspection: 64 days

Shortest Inspection: 1 days

Average Length of Inspection: 9.9 days

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Recent Inspections

DateCompanyCityCountryFEI Number483
2024-09-06Unither Manufacturing LLC.RochesterUnited States1314625
2024-06-11GEN ILAC VE SAGLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI FABRIKA SUBESIAnkaraTurkey3015775861
2024-05-31Diora Kimya Sanayi ve Ticaret Limited SirketiGaziantepTurkey3013927966
2024-05-02United Therapeutics CorporationSilver SpringUnited States3003368324
2023-10-13Fresenius Kabi USA, LLCGrand IslandUnited States3001833549
2023-05-26Patheon Italia S.p.A.MonzaItaly3003065803
2023-05-16ACS Dobfar SPA (Plant #2)TribianoItaly3002806297
2023-03-24Delsam Pharma LLCBronxUnited States3018035065
2022-11-03Advanced Accelerator Applications USA, Inc.MillburnUnited States3012484129
2022-10-04Steri-Pharma, LLCSyracuseUnited States3008585015

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Download 483s and EIRs for Mindy M Chou

Co-Inspectors

NameInspectionsLast Inspection
Sony Mathews112019
Alice S Tsao102017
Helen B Ricalde52017
Robert C Horan42016
Brandy N Lepage32023
Natasha Gupta32022
Philip F Istafanos32019
Rachael A Moliver32016
Gam S Zamil22022
Johnna L Bleem22021
Michael R Dominick22015
Samina S Khan22014
Lauren H Augustyniak12024
Janet A Rajan12024
Annet R Rajan12024
Jazmine N Brown12023
Karishma G Gopaul12022
Victoria Spivak12022
Sayyem H Akbar12022
Robin P Mathew12022
Samir C Gala12022
Nicholas A Violand12022
Ko U Min12022
Guerlain Ulysse12022
Juliana M Badalucco12021
Daniel L Zheng12021
Roseline N Boateng12021
Vivin George12021
Djamila Harouaka12019
Patric C Klotzbuecher12019
Brandon L Mariner12019
Gregson A Joseph12019
Erika E Englund12017
Robert C Steyert12016
Claire O Nicholls12016
Marie B Buen-Bigornia12016
Yvonne M Santiago12015
James A Liubicich12015
Charanjeet Jassal12015

Active Locations

Year-wise Inspection Count