FDA Inspection 999137 — GC Hanford Manufacturing Company
The FDA completed an inspection of GC Hanford Manufacturing Company on Dec 16, 2016 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). 6 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 16, 2016
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Syracuse, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1418 | 21 CFR 211.42(c)(7) | Quarantined Drug Products Area |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |
| 4401 | 21 CFR 211.186(b)(9) | Complete instructions, procedures, specifications et. al. |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |