FDA Inspection 864591 — Boehringer Ingelheim Animal Health Puerto Rico LLC
The FDA completed an inspection of Boehringer Ingelheim Animal Health Puerto Rico LLC on January 28, 2014 in Barceloneta, PR. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 28, 2014
- Fiscal Year
- 2014
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Barceloneta, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |