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FDA Person
•Office of Regulatory Affairs

Brian D. Nicholson

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FDA investigator, Office of Regulatory Affairs. Took part in 36 inspections of 36 companies, 2016–2019.

Inspections (36)
DateCompanyClassificationProject areaInspection
September 5, 2019SCI Pharmtech Inc.NAIDrug Quality Assurance#1106854
August 30, 2019Cheng Fong Chemical Co., Ltd. Dayuan FactoryVAIDrug Quality Assurance#1102734
August 23, 2019Sucampo Pharma, LLCVAIDrug Quality Assurance#1102528
August 6, 2019Paket CorpVAIDrug Quality Assurance#1098750
June 14, 2019Washington University School of MedicineNot classified#1095665
May 30, 2019Grace Analytical Lab IncOAIMonitoring of Marketed Animal Drugs, Feed, and Devices#1092034
April 10, 2019Ridley USA, Inc.VAIMonitoring of Marketed Animal Drugs, Feed, and Devices#1085940
March 8, 2019Fresenius Kabi USA, LLCNAIDrug Quality Assurance#1085354
February 7, 2019Maple City Packaging, LLCNAIDrug Quality Assurance#1079341
January 24, 2019Micro Measurement Laboratories, Inc.VAIMonitoring of Marketed Animal Drugs, Feed, and Devices#1077089
December 11, 2018Empire Distributors, Inc.VAIUnapproved and Misbranded Drugs#1074109
November 29, 2018Combe Laboratories, Inc.NAIMonitoring of Marketed Animal Drugs, Feed, and Devices#1073747
September 26, 2018Boehringer lngelheim Therapeutics GmbhNot classified#1070155
September 21, 2018Bachem SA- Branch VionnazVAIDrug Quality Assurance#1069736
September 14, 2018PCASNAIDrug Quality Assurance#1069557
August 24, 2018AbbVie Inc.NAIMonitoring of Marketed Animal Drugs, Feed, and Devices#1070526
July 25, 2018Orsini Pharmaceutical Services, Inc.Not classified#1060793
June 27, 2018Kalman Health & Wellness, Inc.VAIDrug Quality Assurance#1058276
June 5, 2018A-S Medication Solutions LLCVAIDrug Quality Assurance#1054512
April 18, 2018NorthStar Medical Radioisotopes, LLCNot classified#1048938
See all 36 inspections in the dashboard
Documents (33)
  • 483 · Unknown Company · June 27, 2018
  • 483 · Apollo Care, LLC · September 8, 2021
  • 483 · Option Care Enterprises · February 8, 2018
  • 483 · Axium Healthcare Pharmacy dba Balanced Solutions Compounding · March 15, 2013
  • 483 · Bella Pharmaceuticals, Inc. · August 3, 2017
  • 483 · Morton Grove Pharmaceuticals, Inc. · March 26, 2014
  • WARNING LETTER · Bell International Laboratories, Inc. · September 19, 2023
  • STATE REFERRAL LETTER · SNF Holdings, LLC dba Vios Compounding · February 13, 2023
  • 483 · Akom Pharmaceuticals, Inc. · April 26, 2017
  • 483 · Antares Pharma, Inc · May 13, 2022
  • 483 · Dental Technologies, Inc.
  • EIR · Fresenius Kabi USA, LLC · March 8, 2019
  • 483 · Japan Food Research Laboratories, Chitose Laboratory
  • 483 · Grain Processing Corporation · February 13, 2020
  • 483 · Washington University School of Medicine · June 14, 2019
  • 483 · Sucampo Pharma, LLC
  • 483 · Japan Food Research Laboratories, Chitose Laboratory
  • 483 · Micro Measurement Laboratories, Inc. · January 24, 2019
  • EIR · Kashiv BioSciences, LLC · November 21, 2017
  • 483 · Celgene Corp., d.b.a. Abraxis BioScience LLC · February 26, 2009
  • 483 · Fresenius Kabi USA LLC · May 18, 2020
  • EIR · PetNet Solutions Inc · April 8, 2022
  • 483 · Grace Analytical Lab Inc · September 29, 2021
  • 483 · Sunstar Americas, Inc. · February 18, 2021
  • 483 · Kashiv BioSciences, LLC · November 21, 2017
  • EIR · AndersonBrecon Inc. · June 10, 2022
  • 483 · Thornton Industries, Inc. · March 4, 2020
  • 483 · Fresenius Kabi USA LLC · June 30, 2022
  • 483 · Paket Corp · August 6, 2019
  • 483 · Grace Analytical Lab Inc · May 30, 2019
  • EIR · BMC 1092, Inc. · September 28, 2016
  • EIR · Kashiv BioSciences, LLC · February 9, 2015
  • 483 · Japan Food Research Laboratories, Chitose Laboratory · November 8, 2019
Frequently inspected with (5)
Vioela Respress
3 shared
Alan M. Roberts
1 shared
Diane L. Raccasi
1 shared
Kathleen R. Jones

investigator

1 shared
Krishna Ghosh
1 shared
Related Office
Office of Regulatory Affairs
Person Information

Name

Brian D. Nicholson

Office

Office of Regulatory Affairs

Role

Regulatory Personnel

ID: 83ea13dd-6753-468a-a0ca-19e3ef4158dd

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