FDA Inspection
Ol Pharma Tech LLCOl Pharma Tech LLC – FDA Inspection, Jul 10, 2026
Record Details
This FDA Inspection record concerns Ol Pharma Tech LLC, with an inspection on July 10, 2026, issued by the Detroit District Office, covering human drugs.
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ID · 41c898a8-a99c-4aa5-bdb8-e93fdcb92605
Inspection Facts
- Inspection number
- 1325806
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
12- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.165(f)Failing drug products not rejected
- 21 CFR 211.166(a)Written program not followed
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.63Equipment Design, Size and Location
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Other FDA inspections of Ol Pharma Tech LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 22, 2024 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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