FDA Inspection 1133603 — Allure Labs, LLC
The FDA completed an inspection of Allure Labs, LLC on November 23, 2020 in Hayward, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 23, 2020
- Fiscal Year
- 2021
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Hayward, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 2012 | 21 CFR 211.188(b) | Batch production and Batch Control Record Requirements |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |