FDA Inspection 1155149 — Verde Cosmetic Labs, LLC
The FDA completed an inspection of Verde Cosmetic Labs, LLC on October 15, 2021 in Northridge, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 20 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- October 15, 2021
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Northridge, 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 |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1388 | 21 CFR 211.101(d) | Component addition checked by 2nd person |
| 1395 | 21 CFR 211.103 | Actual vs. theoretical yields not determined |
| 1413 | 21 CFR 211.42(c)(5) | Mfg / Processing Operations Area |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 1976 | 21 CFR 211.182 | Specific information required in individual logs |
| 1978 | 21 CFR 211.182 | Personnel dating/signing equipment log |
| 2008 | 21 CFR 211.186(a) | Written procedures followed |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |
| 4355 | 21 CFR 211.165(c) | Sampling and testing plans not followed |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |
| 4576 | 21 CFR 211.192 | No written record of investigation |