FDA Inspection 1119390 — Cosmetic Essence, LLC.
The FDA completed an inspection of Cosmetic Essence, LLC. on February 28, 2020 in Roanoke, VA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 28, 2020
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Roanoke, VA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1803 | 21 CFR 211.84(b) | Representative Samples Criteria |
| 4323 | 21 CFR 211.115(a) | Reprocessing procedures lack steps to be taken |
| 4576 | 21 CFR 211.192 | No written record of investigation |