Scott R Nichols

FDA Investigator Report

Designation: MICROBIOLOGIST

Duty Station: Silver Spring MD 20993-0002

Organizations: DHHS FDA CDER OMPT CDER OPQ OPF DMA MABIV

Total Inspections: 12

Total 483s Issued: 9

Total Warning Letters Issued: 0

Inspection Details

Longest Inspection: 11 days

Shortest Inspection: 3 days

Average Length of Inspection: 8.0 days

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Recent Inspections

DateCompanyCityCountryFEI Number483
2019-07-02Sanofi Chimie, Division of SanofiVitry Sur SeineFrance3002808000
2019-05-24Chiesi Farmaceutici S.p.A.ParmaItaly3002806655
2018-12-05Abbvie Operations Singapore Pte LtdSingaporeSingapore3011774256
2018-09-28Lonza Biologics PlcSloughUnited Kingdom1000583959
2018-09-12KBI Biopharma, Inc.BoulderUnited States3011326133
2018-05-01Catalent Indiana, LLCBloomingtonUnited States3005949964
2018-02-07Lonza Biologics, Inc.PortsmouthUnited States3001451441
2017-12-21Kyowa Hakko Kirin Co., Ltd.TakasakiJapan3007588904
2017-10-13Sandoz GmbHLangkampfenAustria3004828473
2017-10-03Amgen, Inc.Thousand OaksUnited States2026154

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Co-Inspectors

NameInspectionsLast Inspection
Steven Fong22018
Reyes Candau-Chacon22017
Saleem A Akhtar12019
Ralph M Bernstein12018
Jamie L Dion12018
Nicholas L Paulin12018
Zhong Li12017
Thuy T Nguyen12017
Michael Shanks12017
Kathleen R Jones12017

Active Locations

Year-wise Inspection Count