FDA Inspection
Quality Animal Care Mfg IncQuality Animal Care Mfg Inc – FDA Inspection, Mar 25, 2015
Record Details
This FDA Inspection record concerns Quality Animal Care Mfg Inc, with an inspection on March 25, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Quality Animal Care Mfg Inc
- Inspection Date
- March 25, 2015
- Product Type
- Drugs
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ID · 5afa0c31-bbfa-4d67-9366-8baa6911ef9d
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 917312
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
16- 21 CFR 211.166(b)Adequate number of batches on stability
- 21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.165(f)Failing drug products not rejected
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.110(b)In-process materials specifications testing
- 21 CFR 211.110(c)In-process materials characteristics testing
- 21 CFR 211.165(a)Testing and release for distribution
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