FDA Inspection 867901 — Atlantic Animal Health, Inc. dba Squire Laboratories
The FDA completed an inspection of Atlantic Animal Health, Inc. dba Squire Laboratories on February 26, 2014 in Revere, MA. 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
- February 26, 2014
- Fiscal Year
- 2014
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Revere, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 4325 | 21 CFR 211.110(a) | Control procedures fail to include the following |
| 4351 | 21 CFR 211.160(b)(3) | Drug products - samples representative, identified properly |