FDA Inspection
Mirgen PharmaceuticalMirgen Pharmaceutical – FDA Inspection, Jan 30, 2012
Record Details
This FDA Inspection record concerns Mirgen Pharmaceutical, with an inspection on January 30, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Mirgen Pharmaceutical
- Inspection Date
- January 30, 2012
- Product Type
- Drugs
View Company Profile
ID · 4bdb8a3b-c2fe-4c59-b59b-6cae38643c6f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 764757
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
9- 21 CFR 211.196Distribution Record Requirements
- 21 CFR 211.142(a)Quarantine - actual practice
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.130Procedures are written, and followed
- 21 CFR 211.204Returned drug products identified and held
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.150Written distribution procedure
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