FDA Inspection 769520 — Miramar Cosmetics, Inc
The FDA completed an inspection of Miramar Cosmetics, Inc on March 1, 2012 in Doral, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 1, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Doral, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 15402 | 21 CFR 111.12 | Personnel - quality control personnel - qualified |
| 15410 | 21 CFR 111.14(b)(2) | Personnel - records - training |
| 15529 | 21 CFR 111.30(e) | Equipment - controls, intended use |
| 15589 | 21 CFR 111.160(c) | Packaging, labels - quarantine |
| 15627 | 21 CFR 111.180(b)(3) | Documentation - product received; packaging, labeling |
| 15796 | 21 CFR 111.430(b) | Records - packaging, labeling operations |
| 16070 | 21 CFR 111.35(b)(2) | Document-equipment date of use, maintain, clean, sanitize |