FDA Inspection 805862 — CMI Cosmetic Manufacturers Inc.
The FDA completed an inspection of CMI Cosmetic Manufacturers Inc. on October 24, 2012 in Concord. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 10 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- October 24, 2012
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Concord (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1222 | 21 CFR 211.67(b)(4) | Cleaning SOPs/equipment identification |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 2205 | 21 CFR 211.186(b)(9) | Manufacturing Instructions and Specifications |
| 2569 | 21 CFR 211.198(b) | Maintenance of Complaint File |
| 3561 | 21 CFR 211.56(b) | Written sanitation procedures lacking |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4336 | 21 CFR 211.150 | Written distribution procedure |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |