FDA Inspection
Merix Pharmaceutical CorporationMerix Pharmaceutical Corporation – FDA Inspection, Nov 22, 2010
Record Details
This FDA Inspection record concerns Merix Pharmaceutical Corporation, with an inspection on November 22, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- November 22, 2010
- Product Type
- Drugs
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ID · 18b747c4-fc76-4724-a297-b695a6b76c63
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 697903
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.180(e)(2)Items to cover on annual reviews
- 21 CFR 211.100(a)Approval and review of procedures
- 21 CFR 211.100(b)SOPs not followed / documented
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