FDA Inspection
Bernens Convalescent Pharmacy IncBernens Convalescent Pharmacy Inc – FDA Inspection, Sep 30, 2009
Record Details
This FDA Inspection record concerns Bernens Convalescent Pharmacy Inc, with an inspection on September 30, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- September 30, 2009
- Product Type
- Drugs
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ID · 460959f6-cae0-4de1-b009-c141d25507aa
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 615511
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.110(c)In-process materials characteristics testing
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.130(a)Prevention of cross contamination, mix-ups
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.100(a)Approval and review of procedures
- 21 CFR 211.100(b)SOPs not followed / documented
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