FDA Inspection 1178632 — Miramar Cosmetics, Inc
The FDA completed an inspection of Miramar Cosmetics, Inc on August 31, 2022 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
- August 31, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Unapproved and Misbranded Drugs
- Location
- Doral, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15404 | 21 CFR 111.12(c) | Personnel - education, training, experience |
| 15620 | 21 CFR 111.180(b)(1) | Written procedures - product received |
| 15641 | 21 CFR 111.453 | Written procedures - holding |
| 15796 | 21 CFR 111.430(b) | Records - packaging, labeling operations |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15897 | 21 CFR 111.83(a) | Reserve sample - collect, hold |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 16042 | 21 CFR 111.503 | Written procedures - returned dietary supplement |