FDA Inspection 551817 — Cohere Beauty Holdings LLC
The FDA completed an inspection of Cohere Beauty Holdings LLC on December 10, 2008 in Omaha, NE. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 9 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 10, 2008
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Omaha, NE (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 2007 | 21 CFR 211.186(a) | Signature and checking of records -- 2 persons |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |
| 4369 | 21 CFR 211.188(b)(11) | Identification of persons involved, each significant step |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |