FDA Inspection 935113 — Boehringer Ingelheim Animal Health Puerto Rico LLC
The FDA completed an inspection of Boehringer Ingelheim Animal Health Puerto Rico LLC on Jul 17, 2015 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). 6 citations were issued during this inspection. Product area: Veterinary.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 17, 2015
- Fiscal Year
- 2015
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Barceloneta, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 2007 | 21 CFR 211.186(a) | Signature and checking of records -- 2 persons |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |