FDA Person
Office of the CommissionerJennifer M. Gogley
View detailed information about Jennifer M. Gogley, including compliance records, violations, and related data.
Person Profile
FDA investigator, Office of the Commissioner. Took part in 8 inspections of 7 companies, 2017–2019.
Inspections (8)
| Date | Company | Classification | Project area | Inspection |
|---|---|---|---|---|
| May 14, 2019 | Gilead Sciences, Inc. | NAI | Drug Quality Assurance | #1093610 |
| March 26, 2019 | McGuff Pharmaceuticals, Inc. | VAI | Drug Quality Assurance | #1083919 |
| January 25, 2019 | Opto-Pharm Pte Ltd. | OAI | Drug Quality Assurance | #1078347 |
| January 18, 2019 | Amgen Singapore Manufacturing Pte Ltd | Not classified | #1082474 | |
| March 12, 2018 | Defender SD Manufacturing LLC | OAI | Drug Quality Assurance | #1043973 |
| November 2, 2017 | Nitto Avecia Pharma Services, Inc. | VAI | Generic Drug Evaluation | #1031579 |
| March 31, 2017 | McGuff Pharmaceuticals, Inc. | Not classified | New Drug Evaluation | #1010923 |
| March 31, 2017 | Amphastar Pharmaceuticals, Inc. | OAI | Compliance: Devices | #1009137 |
Documents (11)
- EIR · Teva Parenteral Medicines, Inc. · April 24, 2012
- 483 · Pyramid Laboratories, Inc. · January 15, 2015
- 483 · Hartley Medical Center Pharmacy, Incorporated · July 8, 2015
- 483 · ImprimisRx CA, Inc., dba ImprimisRx · July 2, 2014
- 483 · Avea Biopharmaceuticals LLC · March 23, 2016
- 483 · Opto-Pharm Pte Ltd. · January 25, 2019
- 483 · McGuff Pharmaceuticals, Inc. · March 26, 2019
- 483 · Teva Parenteral Medicines, Inc. · April 24, 2012
- 483 · Teva Parenteral Medicines, Inc. · May 7, 2010
- 483 · Huons Co., Ltd. - Jecheon Factory · October 18, 2019
- 483 · Ajinomoto Althea, Inc. · November 22, 2019
Frequently inspected with (10)
Walden H. Lee
Chemist/Investigator - Pharmaceutical Quality
3 shared
Anastasia M. Shields
Consumer Safety Officer
2 shared
Alan L. Truong
1 shared
Amanda L. Fyles
investigator
1 shared
Amir Alavi
investigator
1 shared
Bryan A. Galvez
Pharmaceutical investigator
1 shared
Carrie A. Hughes
1 shared
Diane R. Weidley
1 shared
Jeffrey P. Raimondi
Consumer Safety Officer
1 shared
Joey V. Quitania
Public Affairs Specialist
1 shared
Related Office
Person Information
Name
Jennifer M. Gogley
Title
Laboratory Director
Role
Regulatory Personnel
ID: 2025f306-80a6-4222-89ac-e4138028292a
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