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Alice S. Tsao

View detailed information about Alice S. Tsao, including compliance records, violations, and related data.

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Person Profile

FDA investigator. Took part in 36 inspections of 33 companies, 2016–2026.

Inspections (36)
DateCompanyClassificationProject areaInspection
March 6, 2026Saptalis Pharmaceuticals LLCNot classifiedDrug Quality Assurance#1305912
August 29, 2023Appco Pharma LLCVAIDrug Quality Assurance#1216223
May 5, 2023Cilag AGNAIDrug Quality Assurance#1208475
April 21, 2023UCB Pharma S.A.Not classified#1208307
March 17, 2023FORDOZ PHARMA CORPORATIONVAI#1201660
September 25, 2019Isomers Laboratories Inc.Not classifiedUnapproved and Misbranded Drugs#1102733
September 17, 2019Baxter CorporationVAIDrug Quality Assurance#1102280
March 29, 2019ARx LLCVAIGeneric Drug Evaluation#1085673
March 18, 2019Amneal Pharmaceuticals of New York, LLCVAIDrug Quality Assurance#1082937
February 1, 2019Epic Pharma, LLCVAIDrug Quality Assurance#1077818
November 9, 2018Pharmaceutics International, Inc.VAIDrug Quality Assurance#1072073
November 9, 2018Pharmaceutics International IncVAINew Drug Evaluation#1071297
August 30, 2018GlaxoSmithKline dba Human Genome Sciences IncNAIDrug Quality Assurance#1068898
August 9, 2018Magellan Rx Pharmacy, LLCNAIDrug Quality Assurance#1066579
June 21, 2018Bioindustria Laboratorio Italiano Medicinali S.p.A.VAIDrug Quality Assurance#1058986
June 15, 2018Bioindustria Laboratorio Italiano Medicinali S.p.ANAIDrug Quality Assurance#1059528
April 20, 2018Sciegen Pharmaceuticals IncNAIDrug Quality Assurance#1052720
March 28, 2018Saptalis Pharmaceuticals LLCVAIDrug Quality Assurance#1046656
February 21, 2018Ascent Pharmaceuticals IncNAIDrug Quality Assurance#1047500
January 10, 2018Chroma Research Labs, Inc.VAIDrug Quality Assurance#1037761
See all 36 inspections in the dashboard
Documents (28)
  • 483 · Professional Disposables International, Inc. · July 5, 2011
  • 483 · William R. Grace M.D. P.C. · July 8, 2016
  • 483 · MasterPharm LLC · January 30, 2017
  • 483 · Magellan Rx Pharmacy, LLC · December 22, 2016
  • EIR · Epic Pharma, LLC · February 1, 2019
  • 483 · UCB Pharma SA, Braine · April 21, 2023
  • EIR · MasterPharm LLC · January 30, 2017
  • EIR · InvaGen Pharmaceuticals, Inc. · March 13, 2012
  • EIR · Shilpa Pharma Lifesciences Limited · March 14, 2025
  • EIR · UCB Pharma S.A. · April 21, 2023
  • EIR · Pharmaceutics International, Inc. · November 9, 2018
  • 483 · UCB Pharma S.A. · April 21, 2023
  • 483 · MannKind Corporation · August 6, 2021
  • 483 · Amneal Pharmaceuticals of New York, LLC · March 18, 2019
  • 483 · Appco Pharma LLC · August 29, 2023
  • 483 · Pharmaceutics International Inc · November 9, 2018
  • EIR · Gemini Pharmaceuticals, Inc. · June 1, 2011
  • 483 · FORDOZ PHARMA CORPORATION · March 17, 2023
  • 483 · ARx LLC · March 29, 2019
  • EIR · Fresenius Kabi USA, LLC · October 24, 2014
  • EIR · Ascent Pharmaceuticals Inc · February 21, 2018
  • 483 · Wong Lap Kwong Medicine Company Limited · September 22, 2017
  • 483 · Gemini Pharmaceuticals, Inc. · June 1, 2011
  • 483 · Wuhan Chinese Moxibustion Technology Dev. Co., Ltd.
  • 483 · Fresenius Kabi USA, LLC · October 24, 2014
  • 483 · Epic Pharma, LLC · February 1, 2019
  • 483 · Hubei Gedian Humanwell Pharmaceutical Co., Ltd. · May 13, 2016
  • 483 · Saptalis Pharmaceuticals LLC · March 6, 2026
Frequently inspected with (10)
Mindy M. Chou
4 shared
Jay T. Wong
3 shared
Rachael A. Moss
3 shared
Simone E. Pitts

National Expert, Pharmaceutical

3 shared
Alison N. Stieg

Staff Director

2 shared
David A. Oluwo

Pharmacy Intern/Certified Pharmacy Technician

2 shared
Michael Shanks
2 shared
Ankur C. Patel
1 shared
Claire O. Nicholls
1 shared
Craig D. Zagata

Investigator

1 shared
Person Information

Name

Alice S. Tsao

Title

Consumer Safety Officer at FDA

Role

Regulatory Personnel

ID: b6d72ceb-de7c-413d-b104-cac3b075c170

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