FDA Inspection 1099540 — Cohere Beauty Holdings LLC
The FDA completed an inspection of Cohere Beauty Holdings LLC on July 3, 2019 in Omaha, NE. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 3, 2019
- Fiscal Year
- 2019
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Omaha, NE (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 1810 | 21 CFR 211.160(a) | Lab controls established, including changes |
| 1891 | 21 CFR 211.165(f) | Failing drug products not rejected |
| 1920 | 21 CFR 211.166(a)(3) | Valid stability test methods |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4404 | 21 CFR 211.194(a)(1) | Sample identification and other information |