FDA Inspection
Quali ControleQuali Controle – FDA Inspection, Sep 15, 2017
Record Details
This FDA Inspection record concerns Quali Controle, with an inspection on September 15, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 55552ad0-e150-424f-98e9-4df89abe87a8
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1025330
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.160(a)Deviations from laboratory control requirements
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Quali Controle
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 13, 2024 | OAI | Office of Inspections and Investigations | Drug Quality Assurance |
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