FDA Inspection 1192748 — Boehringer Ingelheim Animal Health do Brasil Ltda.
The FDA completed an inspection of Boehringer Ingelheim Animal Health do Brasil Ltda. on December 13, 2022 in Paulinia. 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
- December 13, 2022
- Fiscal Year
- 2023
- 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 |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1395 | 21 CFR 211.103 | Actual vs. theoretical yields not determined |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |