FDA Inspection
Cohere Beauty Holdings LLCCohere Beauty Holdings LLC – FDA Inspection, Dec 10, 2008
Record Details
This FDA Inspection record concerns Cohere Beauty Holdings LLC, with an inspection on December 10, 2008, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Cohere Beauty Holdings LLC
- Inspection Date
- December 10, 2008
- Product Type
- Drugs
View Company Profile
ID · e2304103-7b8b-4a6a-b222-448525c0232c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 551817
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
9- 21 CFR 211.188(b)(11)Identification of persons involved, each significant step
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.186(a)Signature and checking of records -- 2 persons
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.166(a)Written program not followed
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
- 21 CFR 211.67(b)Written procedures not established/followed
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Cohere Beauty Holdings LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| July 3, 2019 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| 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 |
Other documents for Cohere Beauty Holdings LLC
- FDA Inspection 1099540 - 2019-07-03
- FDA Inspection 990496 - 2016-10-28
- FDA Inspection 861469 - 2014-01-09
- FDA Inspection 718258 - 2011-04-04
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.