FDA Inspection
ChemRite CoPac LLCChemRite CoPac LLC – FDA Inspection, Jul 15, 2016
Record Details
This FDA Inspection record concerns ChemRite CoPac LLC, with an inspection on July 15, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- ChemRite CoPac LLC
- Inspection Date
- July 15, 2016
- Product Type
- Drugs
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ID · e9db8ef7-cffa-4909-b503-05d15d08c3c8
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 987532
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
8- 21 CFR 211.165(d)Acceptance criteria for sampling & testing
- 21 CFR 211.42(a)Buildings of Suitable Size, Construction, Location
- 21 CFR 211.165(b)Microbiological testing
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.48(a)Plumbing System Defects
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.100(b)SOPs not followed / documented
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Other FDA inspections of ChemRite CoPac LLC
6| Date | Classification | Office | Project area |
|---|---|---|---|
| September 18, 2026 | Not classified | Minneapolis District Office | Drug Quality Assurance |
| April 11, 2023 | VAI | 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 |
| November 21, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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