FDA Inspection 1180348 — RINATI SKIN LLC
The FDA completed an inspection of RINATI SKIN LLC on Sep 22, 2022 in Hawthorne, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 22, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Hawthorne, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1842 | 21 CFR 211.84(d)(1) | Component identity verification |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 2012 | 21 CFR 211.188(b) | Batch production and Batch Control Record Requirements |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 4315 | 21 CFR 211.84(d)(2) | Testing Each Component for Conformity with Specs |