FDA Inspection 1107713 — IBA Inc.
The FDA completed an inspection of IBA Inc. on October 28, 2019 in Sutton, MA. 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
- October 28, 2019
- Fiscal Year
- 2020
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Sutton, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 21199 | 21 CFR 558.6(a)(6) | Caution statement missing for VFD drugs |
| 21227 | 21 CFR 558.6(c)(5) | Distributor notification |
| 21232 | 21 CFR 558.6(c)(8) | Acknowledgement letter |