FDA Inspection 1112627 — Boehringer Ingelheim Pharmaceuticals, Inc.
The FDA completed an inspection of Boehringer Ingelheim Pharmaceuticals, Inc. on Dec 12, 2019 in Ridgefield, CT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 12, 2019
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Ridgefield, CT (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 7480 | 21 CFR 312.50 | Ensuring compliance with plan and protocol |
| 7557 | 21 CFR 312.56(b) | Notification of FDA of termination of investigator |
| 7558 | 21 CFR 312.57(c) | Record retention requirement |