FDA Inspection
P.A. Benjamin Manufacturing Company LimitedP.A. Benjamin Manufacturing Company Limited – FDA Inspection, May 11, 2012
Record Details
This FDA Inspection record concerns P.A. Benjamin Manufacturing Company Limited, with an inspection on May 11, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- May 11, 2012
- Product Type
- Drugs
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ID · 4eb75440-1323-4169-b3b9-8057776d5cc7
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 782903
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
16- 21 CFR 211.188(b)(8)Labeling control records including specimens or copies
- 21 CFR 211.188(b)(1)Dates not included for each significant step
- 21 CFR 211.188(b)(12)Investigations made into any unexplained discrepancy
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.89Quarantine of Rejected Components et. al.
- 21 CFR 211.115(b)Reprocessing/quality control unit
- 21 CFR 211.170(b)Annual visual exams of drug products
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Other FDA inspections of P.A. Benjamin Manufacturing Company Limited
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 11, 2017 | VAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
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