FDA Inspection 991428 — Atlantic Animal Health, Inc. dba Squire Laboratories
The FDA completed an inspection of Atlantic Animal Health, Inc. dba Squire Laboratories on November 2, 2016 in Revere, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 2, 2016
- Fiscal Year
- 2017
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Revere, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1728 | 21 CFR 211.87 | Retest of approved components/containers/closures |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |