FDA Inspection 864591 — Boehringer Ingelheim Animal Health Puerto Rico LLC
The FDA completed an inspection of Boehringer Ingelheim Animal Health Puerto Rico LLC on Jan 28, 2014 in Barceloneta, PR. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 5 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- No Action Indicated (NAI)
- End Date
- Jan 28, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- 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 |