FDA Inspection
Cosmetique Active ProductionFDA Inspection 985371 - Cosmetique Active Production - September 02, 2016
Record Details
This FDA Inspection record concerns Cosmetique Active Production, with an inspection on September 2, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Cosmetique Active Production
- Inspection Date
- September 2, 2016
- Product Type
- Drugs
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ID · 779916be-13a9-4e22-8a63-7268083843ee
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 985371
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
13- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.68(b)Backup file not maintained
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(a)(3)Statement of Sample Weights and Measures
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.165(c)Sampling and testing plans not described
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Other FDA inspections of Cosmetique Active Production
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 12, 2024 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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