FDA Inspection
Hunter Amenities International LimitedHunter Amenities International Limited – FDA Inspection, Mar 22, 2012
Record Details
This FDA Inspection record concerns Hunter Amenities International Limited, with an inspection on March 22, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- March 22, 2012
- Product Type
- Drugs
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ID · 9962626b-d9b9-4abb-b48b-338f521ac602
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 775096
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.22(c)Approve or reject procedures or specs
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.182Written records kept in individual logs
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