FDA Inspection
MultimexMultimex – FDA Inspection, May 12, 2011
Record Details
This FDA Inspection record concerns Multimex, with an inspection on May 12, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Multimex
- Inspection Date
- May 12, 2011
- Product Type
- Drugs
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ID · 5f4ccdcc-9fb8-44f2-9f9b-20b25689a885
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 726080
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
8- 21 CFR 211.180(b)Record maintenance 1 year (except exempt OTC)
- 21 CFR 211.150(b)Recall facilitation
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.150(a)Distribution of oldest approved drugs
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
- 21 CFR 211.142(a)Quarantine - written procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Multimex
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 20, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 24, 2011 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Multimex
- FDA Inspection 800145 - 2012-09-20
- FDA Inspection 706878 - 2011-01-24
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