708255
Miramar Cosmetics, Inc — FEI 3004486512
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- February 14, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Unapproved and Misbranded Drugs
- Location
- Doral, FL (United States)
Citations
| ID | CFR | Description |
|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1227 | 21 CFR 211.67(c) | Cleaning/maintenance records not kept |
| 1261 | 21 CFR 211.68(a) | Written calibration / inspection records not kept |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1633 | 21 CFR 211.130(d) | Examination of packaging and labeling |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 2003 | 21 CFR 211.184(c) | Individual inventory record |
| 2012 | 21 CFR 211.188(b) | Batch production and Batch Control Record Requirements |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 4306 | 21 CFR 211.80(a) | Written Procedures Not Followed |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4321 | 21 CFR 211.101(b) | Identification of new containers |
| 4418 | 21 CFR 211.42(b) | Adequate space lacking to prevent mix-ups and contamination |