FDA Inspection 715648 — GC Hanford Manufacturing Company
The FDA completed an inspection of GC Hanford Manufacturing Company on Mar 4, 2011 in Syracuse, NY. 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). 5 citations were issued during this inspection. Product area: Veterinary.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 4, 2011
- Fiscal Year
- 2011
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Syracuse, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1976 | 21 CFR 211.182 | Specific information required in individual logs |
| 4302 | 21 CFR 211.56(b) | Written sanitation procedures not followed |
| 4355 | 21 CFR 211.165(c) | Sampling and testing plans not followed |
| 4375 | 21 CFR 211.188(b)(5) | In-process and laboratory control results |