Diane L Raccasi

FDA Investigator Report

Designation: MICROBIOLOGIST

Duty Station: Silver Spring MD 20993-0002

Organizations: DHHS FDA CDER OMPT CDER OPQ OPF DMA MABIV

Total Inspections: 14

Total 483s Issued: 14

Total Warning Letters Issued: 0

Inspection Details

Longest Inspection: 11 days

Shortest Inspection: 5 days

Average Length of Inspection: 7.8 days

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Recent Inspections

DateCompanyCityCountryFEI Number483
2019-05-02Tanvex BioPharma USA, IncSan DiegoUnited States3013021112
2019-02-15Biocon Biologics LimitedBengaluruIndia3003981475
2018-09-21Boehringer Ingelheim Pharma Gmbh & Co KgBiberach An Der RisGermany3002806518
2018-08-24QOL Medical LLCClearwaterUnited States3014492051
2018-07-17Boehringer Ingelheim RCV GmbH & Co KGViennaAustria3003433722
2018-05-11Samsung Biologics Co., Ltd.YeonsuKorea (the Republic of)3010479596
2017-11-21Kashiv BioSciences, LLCChicagoUnited States3011289655
2017-08-18Alexion Pharma International Operations Unlimited Co.AthloneIreland3011532960
2017-08-11Sanofi GenzymeAllstonUnited States1000305672
2017-05-23Rentschler Biopharma SELaupheimGermany1000291122

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Co-Inspectors

NameInspectionsLast Inspection
Michael Shanks32019
Maria J Lopez- Barragan32017
Wayne E Seifert22017
Maria I Cruz-Fisher22017
Frances Namuswe12019
Lindsey J Brown12019
Thuy T Nguyen12019
Amanda L Fyles12019
Ruth A Moore12017
Zhong Li12017
Maxwell L Van Tassell12017
Ephrem T Hunde12017
Monica M Commerford12017
Kristin M Abaonza12017
Jessica Hankins12017
Steven Fong12017
Brian D Nicholson12017
Kathleen R Jones12017
Edmund F Mrak12017

Active Locations

Year-wise Inspection Count