FDA Inspection 1003657 — Boehringer Ingelheim Animal Health do Brasil Ltda.
The FDA completed an inspection of Boehringer Ingelheim Animal Health do Brasil Ltda. on February 7, 2017 in Paulinia. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 7, 2017
- Fiscal Year
- 2017
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Paulinia (Brazil)
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 |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |