FDA Inspection 1037221 — Flawless Beauty and Skin
The FDA completed an inspection of Flawless Beauty and Skin on January 10, 2018 in Ocean, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 10, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Ocean, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 10005 | n/a | Procedural requirements |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1774 | 21 CFR 211.142(a) | Quarantine - actual practice |
| 1777 | 21 CFR 211.150(b) | Distribution Recall System |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |
| 4414 | 21 CFR 211.204 | Record information maintained |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |