FDA Inspection
Cohere Beauty Holdings LLCCohere Beauty Holdings LLC – FDA Inspection, Jul 3, 2019
Record Details
This FDA Inspection record concerns Cohere Beauty Holdings LLC, with an inspection on July 3, 2019, issued by the Center for Veterinary Medicine, covering veterinary.
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ID · 1fcc97fc-ddce-4b29-b7f1-02484475b35c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1099540
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.165(f)Failing drug products not rejected
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(a)(1)Sample identification and other information
- 21 CFR 211.160(a)Lab controls established, including changes
- 21 CFR 211.166(a)(3)Valid stability test methods
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Other FDA inspections of Cohere Beauty Holdings LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| October 28, 2016 | NAI | Kansas City District Office | Colors and Cosmetics Technology |
| January 9, 2014 | NAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
| April 4, 2011 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| December 10, 2008 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Cohere Beauty Holdings LLC
- FDA Inspection 990496 - 2016-10-28
- FDA Inspection 861469 - 2014-01-09
- FDA Inspection 718258 - 2011-04-04
- FDA Inspection 551817 - 2008-12-10
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