FDA Inspection 654802 — Cosmetic Science Laboratories, LLC
The FDA completed an inspection of Cosmetic Science Laboratories, LLC on March 31, 2010 in Torrance, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 17 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 31, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Torrance, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1136 | 21 CFR 211.25(c) | Inadequate number of personnel |
| 1411 | 21 CFR 211.105(b) | Distinctive ID or code not recorded in batch record |
| 1632 | 21 CFR 211.130(c) | Lot or control number assigned |
| 1633 | 21 CFR 211.130(d) | Examination of packaging and labeling |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 2007 | 21 CFR 211.186(a) | Signature and checking of records -- 2 persons |
| 2019 | 21 CFR 211.188(b)(7) | Documentation of Actual Yield and Theoretical Yield |
| 2021 | 21 CFR 211.188(b)(9) | Container/Closure Description |
| 2034 | 21 CFR 211.194(d) | Laboratory equipment calibration records |
| 3581 | 21 CFR 211.101(d) | Verification of component addition |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 3605 | 21 CFR 211.160(b)(1) | Specification description of sample/testing |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4370 | 21 CFR 211.188(b)(10) | Records of any sampling performed |
| 4372 | 21 CFR 211.188(b)(8) | Labeling control records including specimens or copies |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |