FDA Inspection 1262182 — Columbia Cosmetics Manufacturing, Inc.
The FDA completed an inspection of Columbia Cosmetics Manufacturing, Inc. on April 14, 2025 in San Leandro, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 14, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- San Leandro, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1220 | 21 CFR 211.67(b)(3) | Cleaning SOPs/instructions |
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |
| 1891 | 21 CFR 211.165(f) | Failing drug products not rejected |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |