FDA Inspection 1100413 — Morgan Gallacher
The FDA completed an inspection of Morgan Gallacher on Aug 23, 2019 in Santa Fe Springs, CA. 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
- Aug 23, 2019
- Fiscal Year
- 2019
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Santa Fe Springs, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1891 | 21 CFR 211.165(f) | Failing drug products not rejected |
| 4323 | 21 CFR 211.115(a) | Reprocessing procedures lack steps to be taken |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |