FDA Inspection 737214 — Advanced Cosmetic Research Laboratories, Inc.
The FDA completed an inspection of Advanced Cosmetic Research Laboratories, Inc. on August 1, 2011 in Chatsworth, 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) (VAI)
- End Date
- August 1, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Chatsworth, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1796 | 21 CFR 211.80(d) | Identification of Each Lot in Each Shipment |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4328 | 21 CFR 211.122(a) | Written procedures 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 |