FDA Inspection
Quali ControleQuali Controle – FDA Inspection, Dec 13, 2024
Record Details
This FDA Inspection record concerns Quali Controle, with an inspection on December 13, 2024, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · 72ebc2a3-09ce-4069-ad44-b8dd7a215d9f
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1256932
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
2- 21 CFR 211.165(e)Test methods
- 21 CFR 211.192Investigations of discrepancies, failures
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Other FDA inspections of Quali Controle
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 15, 2017 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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