FDA Inspection 695241 — Allure Labs, LLC
The FDA completed an inspection of Allure Labs, LLC on November 22, 2010 in Hayward, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 21 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 22, 2010
- Fiscal Year
- 2011
- 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 |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1395 | 21 CFR 211.103 | Actual vs. theoretical yields not determined |
| 1411 | 21 CFR 211.105(b) | Distinctive ID or code not recorded in batch record |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1496 | 21 CFR 211.122(a) | Sampling/testing of labeling/packaging materials |
| 1774 | 21 CFR 211.142(a) | Quarantine - actual practice |
| 1796 | 21 CFR 211.80(d) | Identification of Each Lot in Each Shipment |
| 1851 | 21 CFR 211.84(e) | Rejecting When Specifications Not Met |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 1891 | 21 CFR 211.165(f) | Failing drug products not rejected |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |
| 3592 | 21 CFR 211.110(c) | In-process materials characteristics testing |
| 4315 | 21 CFR 211.84(d)(2) | Testing Each Component for Conformity with Specs |
| 4351 | 21 CFR 211.160(b)(3) | Drug products - samples representative, identified properly |
| 4406 | 21 CFR 211.194(a)(2) | Suitability of testing methods verified |
| 4413 | 21 CFR 211.194(a)(8) | Second person sign off |