764765
Andapharm, LLC — FEI 3005000348
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 7, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Fort Lauderdale, FL (United States)
Citations
| ID | CFR | Description |
|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1194 | 21 CFR 211.42(c) | Defined areas of adequate size for operations |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 1920 | 21 CFR 211.166(a)(3) | Valid stability test methods |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2619 | 21 CFR 211.198(b)(2) | Complaint Investigation/Follow-Up Findings |