FDA Inspection 1264589 — GC Hanford Manufacturing Company
The FDA completed an inspection of GC Hanford Manufacturing Company on March 20, 2025 in Syracuse, NY. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 20, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Syracuse, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1430 | 21 CFR 211.42(c)(10)(i) | Floors, walls, ceiling surfaces |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 3559 | 21 CFR 211.56(a) | Sanitation--buildings not clean, free of infestation |