FDA Inspection 1030713 — Allure Labs, LLC
The FDA completed an inspection of Allure Labs, LLC on Oct 25, 2017 in Hayward, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 25, 2017
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Hayward, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 3629 | 21 CFR 211.170(b) | Reserve samples identified, representative, stored |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |
| 4306 | 21 CFR 211.80(a) | Written Procedures Not Followed |
| 4340 | 21 CFR 211.142 | Written warehousing procedures established/followed |