FDA Inspection 717096 — Boehringer Ingelheim Animal Health Puerto Rico LLC
The FDA completed an inspection of Boehringer Ingelheim Animal Health Puerto Rico LLC on March 31, 2011 in Barceloneta, PR. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 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 |