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  5. Gayle S. Lawson
FDA Person
•Department of Health and Human Services

Gayle S. Lawson

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FDA investigator, Department of Health and Human Services. Took part in 10 inspections of 10 companies, 2017–2019.

Inspections (10)
DateCompanyClassificationProject areaInspection
June 14, 2019Afton Scientific, LLCVAIDrug Quality Assurance#1092986
August 22, 2018Central Admixture Pharmacy Services, Inc.VAIDrug Quality Assurance#1063439
June 8, 2018Advanced Accelerator Applications (Italy) S.r.l.VAIDrug Quality Assurance#1055374
January 24, 2018KVK Tech, Inc.OAIGeneric Drug Evaluation#1038700
December 7, 2017Almac Pharma Services LLCOAIGeneric Drug Evaluation#1034114
July 20, 2017Frontida BioPharm IncNot classified#1030391
July 20, 2017Frontida BioPharm IncNAIDrug Quality Assurance#1027425
April 14, 2017Micro Labs LimitedNAIDrug Quality Assurance#1019576
April 4, 2017Dr. Reddy's Laboratories Limited CTO VIOAIDrug Quality Assurance#1011964
February 17, 2017Mihalko Medical, LLCOAIDrug Quality Assurance#1004197
Documents (12)
  • 483 · Dr. Reddy's Laboratories Limited CTO VI · April 4, 2017
  • 483 · Mihalko Medical, LLC · February 17, 2017
  • 483 · ImprimisRx Pharmacy LLC · August 1, 2016
  • 483 · Central Admixture Pharmacy Services, Inc. · August 22, 2018
  • 483 · WuXi AppTec, Inc. · April 13, 2015
  • 483 · Johnson Matthey Inc. (dba Johnson Matthey Pharm. Materials) · August 27, 2015
  • 483 · WuXi Advanced Therapies · April 17, 2015
  • EIR · Afton Scientific, LLC · June 14, 2019
  • 483 · Almac Pharma Services LLC · December 7, 2017
  • 483 · Apitoria Pharma Private Limited · October 25, 2019
  • 483 · Afton Scientific, LLC · June 14, 2019
  • EIR · WuXi Advanced Therapies · April 17, 2015
Frequently inspected with (6)
Kenneth H. Williams
2 shared
Christina K. Theodorou

Consumer Safety Officer

1 shared
Ko U. Min

Consumer Safety Officer at FDA U.S. Food and Drug Administration

1 shared
Lisa B. Orr
1 shared
William J. Leonard
1 shared
Zhongren Wu

Principal Consultant

1 shared
Related Office
Department of Health and Human Services
Person Information

Name

Gayle S. Lawson

Title

PreApproval Manager

Office

Department of Health and Human Services

Role

Regulatory Personnel

ID: cd8061de-f089-408c-bbfc-c7c7a5635dd7

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