FDA Inspection 634442 — GCP Laboratories
The FDA completed an inspection of GCP Laboratories on December 9, 2009 in Gulfport, MS. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 9, 2009
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Gulfport, MS (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 9792 | 21 CFR 106.30(b)(3) | Stability analysis |