FDA Inspection
ChemRite CoPac LLCChemRite CoPac LLC – FDA Inspection, Nov 21, 2011
Record Details
This FDA Inspection record concerns ChemRite CoPac LLC, with an inspection on November 21, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- ChemRite CoPac LLC
- Inspection Date
- November 21, 2011
- Product Type
- Drugs
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ID · de204c86-a404-4b65-bfa0-7e4ccafd4f25
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 756820
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.194(a)(2)Statement of methods and data
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of ChemRite CoPac LLC
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|---|---|---|---|
| September 18, 2026 | Not classified | Minneapolis District Office | Drug Quality Assurance |
| April 11, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 15, 2016 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 24, 2016 | VAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
| February 21, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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