FDA Inspection
Laboratoires ClarinsLaboratoires Clarins – FDA Inspection, Sep 21, 2018
Record Details
This FDA Inspection record concerns Laboratoires Clarins, with an inspection on September 21, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · c37a796f-7f08-4a00-9588-dd50a37fe6e9
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1066301
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
- Enforcement
- Warning Letter
FDA Citations
8- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.165(f)Failing drug products not rejected
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.67(b)Written procedures fail to include
- 21 CFR 211.192Written record of investigation incomplete
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Other FDA inspections of Laboratoires Clarins
2| Date | Classification | Office | Project area |
|---|---|---|---|
| October 14, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 21, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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