563778
GCP Laboratories — FEI 1019058
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- February 19, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Gulfport, MS (United States)
Citations
| ID | CFR | Description |
|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1371 | 21 CFR 211.101(a) | Batches Formulated to less than 100% |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 1920 | 21 CFR 211.166(a)(3) | Valid stability test methods |
| 1938 | 21 CFR 211.167(c) | Controlled release dosage form testing |
| 2033 | 21 CFR 211.194(c) | Testing and standardization of standards et. al. |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4343 | 21 CFR 211.160(b)(1) | Incoming lots - conformance to written specs- |