FDA Inspection
Pure Chem IncPure Chem Inc – FDA Inspection, Jul 13, 2011
Record Details
This FDA Inspection record concerns Pure Chem Inc, with an inspection on July 13, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Pure Chem Inc
- Inspection Date
- July 13, 2011
- Product Type
- Drugs
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ID · 62dcb7d3-e044-4870-b074-031672ae08fc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 733810
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
12- 21 CFR 211.166(b)Adequate number of batches on stability
- 21 CFR 211.150(b)Recall facilitation
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.170(b)(1)Retention time of reserve samples, in general
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 21 CFR 211.84(d)(1)Identity Testing of Each Component
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Other FDA inspections of Pure Chem Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 19, 2013 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
Other documents for Pure Chem Inc
- FDA Inspection 828629 - 2013-04-19
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