FDA Inspection 717096 — Boehringer Ingelheim Animal Health Puerto Rico LLC
The FDA completed an inspection of Boehringer Ingelheim Animal Health Puerto Rico LLC on Mar 31, 2011 in Barceloneta, PR. 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). 4 citations were issued during this inspection. Product area: Veterinary.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 31, 2011
- Fiscal Year
- 2011
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Barceloneta, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 3629 | 21 CFR 211.170(b) | Reserve samples identified, representative, stored |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |