FDA Person
FDAAmy N. Chen
View detailed information about Amy N. Chen, including compliance records, violations, and related data.
Person Profile
FDA investigator. Took part in 14 inspections of 14 companies, 2023–2024.
Inspections (14)
| Date | Company | Classification | Project area | Inspection |
|---|---|---|---|---|
| May 15, 2024 | AAA Pharmaceutical, Inc. | VAI | Drug Quality Assurance | #1238562 |
| March 29, 2024 | Keen Compressed Gas Company, Inc. | NAI | Drug Quality Assurance | #1236516 |
| January 25, 2024 | Nanjing White Whale Pharmaceutical Co., Ltd. | Not classified | #1228562 | |
| January 19, 2024 | Nanjing Xingyin Pharmaceutical Group Co. Ltd. | VAI | Drug Quality Assurance | #1228230 |
| January 12, 2024 | Changzhou Pharmaceutical Factory | VAI | Drug Quality Assurance | #1228229 |
| December 18, 2023 | Aerosol and Liquid Packaging, Inc. | OAI | Drug Quality Assurance | #1225284 |
| September 27, 2023 | Piramal Critical Care, Inc. | VAI | Monitoring of Marketed Animal Drugs, Feed, and Devices | #1218865 |
| August 8, 2023 | Hybio Pharmaceutical Co., Ltd. (Pingshan Factory) | Not classified | #1214713 | |
| July 28, 2023 | Zhejiang Huahai Pharmaceutical Technology Co., Ltd. | Not classified | #1218117 | |
| July 21, 2023 | Tianjin Hope Technology Testing Co.,Ltd. | Not classified | #1214716 | |
| June 7, 2023 | Bayer HealthCare LLC | NAI | Drug Quality Assurance | #1209567 |
| April 6, 2023 | Afton Scientific, LLC | VAI | Drug Quality Assurance | #1202143 |
| February 15, 2023 | Veranova LP | VAI | Drug Quality Assurance | #1197654 |
| January 27, 2023 | Modavar Pharmaceuticals | VAI | Generic Drug Evaluation | #1196541 |
Documents (11)
- 483 · Central Admixture Pharmacy Services, Inc. · May 4, 2022
- 483 · ProRx LLC · August 2, 2024
- EIR · Abbott Laboratories · September 24, 2019
- 483 · Aerosol and Liquid Packaging, Inc. · December 18, 2023
- EIR · Veranova LP · March 15, 2023
- 483 · Veranova LP · February 15, 2023
- 483 · Piramal Critical Care, Inc. · September 27, 2023
- 483 · Afton Scientific, LLC · April 6, 2023
- 483 · Changzhou Pharmaceutical Factory · January 12, 2024
- 483 · Modavar Pharmaceuticals · January 27, 2023
- 483 · ImprimisRx NJ · August 5, 2022
Frequently inspected with (10)
Junho Pak
Investigator
3 shared
Rajiv R. Srivastava
Consumer Safety Officer
3 shared
James M. Mason
1 shared
Jazmine N. Brown
1 shared
Jonah S. Ufferfilge
Regional Manager
1 shared
Karen A. Briggs
Investigator
1 shared
Kathleen M. Jordan
1 shared
Kristina L. Conroy
Investigator
1 shared
Rachael O. Oyewole
1 shared
Yoriann M. Cabrera Bartolomei
1 shared
Person Information
Name
Amy N. Chen
Title
Investigator
Role
Regulatory Personnel
ID: c3515e0e-dbb9-4540-bd2b-82c06d00dd42
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