FDA Inspection 1141156 — Zoetis LLC
The FDA completed an inspection of Zoetis LLC on May 3, 2021 in Kalamazoo, MI. 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). 7 citations were issued during this inspection. Product area: Veterinary.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 3, 2021
- Fiscal Year
- 2021
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Kalamazoo, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1033 | 21 CFR 211.22(a) | Authority lacking to review records, investigate errors |
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1435 | 21 CFR 211.42(c)(10)(v) | Cleaning System |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 3559 | 21 CFR 211.56(a) | Sanitation--buildings not clean, free of infestation |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |