FDA Inspection
Coty US LLCCoty US LLC – FDA Inspection, Oct 27, 2021
Record Details
This FDA Inspection record concerns Coty US LLC, with an inspection on October 27, 2021, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Coty US LLC
- Inspection Date
- October 27, 2021
- Product Type
- Drugs
View Company Profile
ID · 60146f86-0fd5-4b2f-921b-9c71f3329972
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1155278
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
9- 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 211.196Distribution Record Requirements
- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.84(d)(2)Component identification test
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.182Written records kept in individual logs
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Coty US LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| September 16, 2026 | VAI | Atlanta District Office | Drug Quality Assurance |
| March 22, 2017 | NAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
| January 12, 2012 | NAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
Other documents for Coty US LLC
- FDA Inspection 1318404 - 2026-09-16
- FDA Inspection 1019364 - 2017-03-22
- FDA Inspection 763048 - 2012-01-12
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