FDA Inspection 694940 — Columbia Cosmetics Manufacturing, Inc.
The FDA completed an inspection of Columbia Cosmetics Manufacturing, Inc. on Dec 17, 2010 in San Leandro, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 17, 2010
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- San Leandro, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1796 | 21 CFR 211.80(d) | Identification of Each Lot in Each Shipment |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 3569 | 21 CFR 211.89 | Quarantine of Rejected Components et. al. |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |