FDA Person
Department of Health and Human ServicesKevin P. Regan
View detailed information about Kevin P. Regan, including compliance records, violations, and related data.
Person Profile
FDA investigator, Department of Health and Human Services. Took part in 14 inspections of 14 companies, 2023–2025.
Inspections (14)
| Date | Company | Classification | Project area | Inspection |
|---|---|---|---|---|
| June 20, 2025 | Flamma USA LLC | Not classified | #1276991 | |
| May 17, 2024 | Mylan Laboratories Limited | VAI | Drug Quality Assurance | #1237801 |
| May 3, 2024 | Alaina Healthcare Private Limited | VAI | Drug Quality Assurance | #1238331 |
| March 1, 2024 | IntegraDose Compounding Services LLC | OAI | Drug Quality Assurance | #1231700 |
| January 19, 2024 | Aurora Pharmaceutical, Inc. | NAI | Monitoring of Marketed Animal Drugs, Feed, and Devices | #1231561 |
| November 8, 2023 | HQ Pharma (Shanghai) Co., Ltd. | VAI | #1223658 | |
| November 3, 2023 | Ningbo Shuangcheng Pharmaceutical Co., Ltd | VAI | #1223659 | |
| October 27, 2023 | Zhejiang Clairvoyant Pharmaceutical Technology Co., Ltd. | VAI | #1223660 | |
| October 17, 2023 | ProMed Pharma, LLC | VAI | Drug Quality Assurance | #1220556 |
| August 1, 2023 | Nanjing MilestonePharma Co. Ltd. | VAI | #1215544 | |
| July 28, 2023 | Shandong Zouping Dazhan New Materials Co., Ltd. | Not classified | #1215545 | |
| July 21, 2023 | Yichang Humanwell Oral Solid Dosage Plant | NAI | Drug Quality Assurance | #1215546 |
| May 10, 2023 | HP Halden Pharma AS | VAI | Drug Quality Assurance | #1205610 |
| April 28, 2023 | Intervet International GmbH | VAI | Monitoring of Marketed Animal Drugs, Feed, and Devices | #1203785 |
Documents (14)
- 483 · IntegraDose Compounding Services LLC · August 2, 2021
- 483 · IntegraDose Compounding Services LLC · March 1, 2024
- 483 · Hydrox Laboratories · June 24, 2021
- 483 · Intervet International GmbH · April 28, 2023
- 483 · Ningbo Shuangcheng Pharmaceutical Co., Ltd · November 3, 2023
- 483 · CHRI Laboratories, Inc. · June 14, 2022
- EIR · Hydrox Laboratories · June 24, 2021
- 483 · Bora Pharmaceuticals Inc. · August 30, 2022
- 483 · ProMed Pharma, LLC · October 17, 2023
- 483 · Flamma USA LLC · June 20, 2025
- 483 · HP Halden Pharma AS · May 10, 2023
- 483 · L'Oreal Usa, Inc. · September 30, 2022
- 483 · Ningbo Shuangcheng Pharmaceutical Co., Ltd. · November 3, 2023
- 483 · Mylan Laboratories Limited · May 17, 2024
Frequently inspected with (8)
Related Office
Person Information
Name
Kevin P. Regan
Title
GDUFA Pharmaceutical Investigator
Role
Regulatory Personnel
ID: b870e1f2-017c-44ab-bc99-1ca99b474a04
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