FDA Inspection
Ol Pharma Tech LLCOl Pharma Tech LLC – FDA Inspection, Jul 22, 2024
Record Details
This FDA Inspection record concerns Ol Pharma Tech LLC, with an inspection on July 22, 2024, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 204f6a3c-0c9e-44eb-9495-02bba49278ce
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1244373
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
9- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Ol Pharma Tech LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 10, 2026 | Not classified | Detroit District Office | Drug Quality Assurance |
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