FDA Inspection
ChemRite CoPac LLCChemRite CoPac LLC – FDA Inspection, Sep 18, 2026
Record Details
This FDA Inspection record concerns ChemRite CoPac LLC, with an inspection on September 18, 2026, issued by the Minneapolis District Office, covering human drugs.
- Person
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ID · 4a38af1e-2097-44ac-9d28-a40e9a9f1c30
Inspection Facts
- Inspection number
- 1336320
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.165(b)Microbiological testing
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.84(b)Representative Samples Criteria
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Other FDA inspections of ChemRite CoPac LLC
6| Date | Classification | Office | Project area |
|---|---|---|---|
| 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 |
| November 21, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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