FDA Inspection 681800 — Cosmetic Specialty Labs, Inc
The FDA completed an inspection of Cosmetic Specialty Labs, Inc on September 22, 2010 in Lawton, OK. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 10 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 22, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Lawton, OK (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 2003 | 21 CFR 211.184(c) | Individual inventory record |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4317 | 21 CFR 211.84(d)(3) | Certificates of Testing (Containers, Closures) |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |
| 4372 | 21 CFR 211.188(b)(8) | Labeling control records including specimens or copies |
| 4377 | 21 CFR 211.188(b)(3) | Identification of each component or in-process material |