FDA Inspection
Cosmetique Active ProductionFDA Inspection 1231481 - Cosmetique Active Production - April 12, 2024
Record Details
This FDA Inspection record concerns Cosmetique Active Production, with an inspection on April 12, 2024, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 2afc5235-b229-41f1-9444-ce96e7545b7e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1231481
- 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 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(a)(4)Data secured in course of each test
- 21 CFR 211.170(b)Reserve samples identified, representative, stored
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
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Other FDA inspections of Cosmetique Active Production
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 2, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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