709026
Buckeye International Inc — FEI 3001419679
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 4, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Maryland Heights, MO (United States)
Citations
| ID | CFR | Description |
|---|
| 1098 | 21 CFR 211.22(c) | Approve or reject procedures or specs |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1136 | 21 CFR 211.25(c) | Inadequate number of personnel |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1505 | 21 CFR 211.122(d) | Label storage access limited to authorized personnel |
| 1509 | 21 CFR 211.122(h) | Printing devices |
| 1844 | 21 CFR 211.84(d)(2) | Establish reliability of supplier's C of A |
| 1876 | 21 CFR 211.180(b) | Record maintenance 1 year (except exempt OTC) |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2569 | 21 CFR 211.198(b) | Maintenance of Complaint File |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3613 | 21 CFR 211.160(b)(4) | Establishment of calibration procedures |
| 4348 | 21 CFR 211.160(b)(2) | In-process materials - sampling, testing procedures |
| 4368 | 21 CFR 211.188(b)(12) | Investigations made into any unexplained discrepancy |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |