782903
P.A. Benjamin Manufacturing Company Limited — FEI 3004341688
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 11, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Kingston (Jamaica)
Citations
| ID | CFR | Description |
|---|
| 1033 | 21 CFR 211.22(a) | Authority lacking to review records, investigate errors |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1456 | 21 CFR 211.115(b) | Reprocessing/quality control unit |
| 2007 | 21 CFR 211.186(a) | Signature and checking of records -- 2 persons |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 3562 | 21 CFR 211.56(c) | Written procedures lacking for use of pesticides etc. |
| 3567 | 21 CFR 211.84(d)(2) | Component identification test |
| 3569 | 21 CFR 211.89 | Quarantine of Rejected Components et. al. |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |
| 4368 | 21 CFR 211.188(b)(12) | Investigations made into any unexplained discrepancy |
| 4372 | 21 CFR 211.188(b)(8) | Labeling control records including specimens or copies |
| 4373 | 21 CFR 211.188(b)(7) | Actual yield, % of theoretical yield |
| 4379 | 21 CFR 211.188(b)(1) | Dates not included for each significant step |