FDA Inspection
RePharm LLCRePharm LLC – FDA Inspection, Jun 25, 2021
Record Details
This FDA Inspection record concerns RePharm LLC, with an inspection on June 25, 2021, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- RePharm LLC
- Inspection Date
- June 25, 2021
- Product Type
- Drugs
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ID · d1db2e42-ffe7-44df-afa3-15cd465cca82
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1145918
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
8- 21 CFR 211.166(b)Adequate number of batches on stability
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.100(a)Absence of Written Procedures
- 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 RePharm LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 15, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 3, 2019 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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