FDA Inspection 1192748 — Boehringer Ingelheim Animal Health Do Brasil Ltda.
The FDA completed an inspection of Boehringer Ingelheim Animal Health Do Brasil Ltda. on Dec 13, 2022 in Paulinia. 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). 4 citations were issued during this inspection. Product area: Veterinary.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 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 |