FDA Inspection
Gemini Packaging Ltd.Gemini Packaging Ltd. – FDA Inspection, Dec 19, 2014
Record Details
This FDA Inspection record concerns Gemini Packaging Ltd., with an inspection on December 19, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Gemini Packaging Ltd.
- Inspection Date
- December 19, 2014
- Product Type
- Drugs
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ID · fd07cd4b-4c88-4448-a353-5991633e0dd9
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 909650
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
18- 21 CFR 211.122(d)Label storage access limited to authorized personnel
- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 211.165(f)Failing drug products not rejected
- 21 CFR 211.130(e)Packaging line inspection before use
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.180(e)Records reviewed annually
- 21 CFR 211.110(d)Rejected in-process materials not quarantined
- 21 CFR 211.115(a)Reprocessing procedures lack steps to be taken
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
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