FDA Inspection
LVMH Fragrance BrandsLVMH Fragrance Brands – FDA Inspection, Sep 23, 2016
Record Details
This FDA Inspection record concerns LVMH Fragrance Brands, with an inspection on September 23, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- LVMH Fragrance Brands
- Inspection Date
- September 23, 2016
- Product Type
- Drugs
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ID · 6be74d96-b405-4487-8112-28d9a6dd52fb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 988788
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
15- 21 CFR 211.166(b)Adequate number of batches on stability
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 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 211.25(a)GMP Training Frequency
- 21 CFR 211.194(a)(4)Data secured in course of each test
- 21 CFR 211.194(a)(8)Second person sign off
- 21 CFR 211.115(a)Reprocessing procedures lack steps to be taken
- 21 CFR 211.170(b)Annual visual exams of drug products
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Other FDA inspections of LVMH Fragrance Brands
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 13, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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