FDA Inspection
RePharm LLCRePharm LLC – FDA Inspection, Jul 3, 2019
Record Details
This FDA Inspection record concerns RePharm LLC, with an inspection on July 3, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 0976a25f-4524-479d-bdea-a9895ac824d8
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1095778
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 211.166(b)Adequate number of batches on stability
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.130(d)Examination of packaging and labeling
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.100(a)Approval and review of procedures
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Other FDA inspections of RePharm LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 15, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 25, 2021 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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