FDA Inspection 1017914 — Doral Pharmamedics, Inc.
The FDA completed an inspection of Doral Pharmamedics, Inc. on July 14, 2017 in Doral, FL. 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: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 14, 2017
- Fiscal Year
- 2017
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Doral, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12720 | 21 CFR 1.225 | Not registered |
| 15401 | 21 CFR 111.12(b) | Personnel - quality control operations; identified |
| 15404 | 21 CFR 111.12(c) | Personnel - education, training, experience |
| 15538 | 21 CFR 111.255(d) | Batch record - readily available |
| 15755 | 21 CFR 111.205(c) | Master manufacturing record: readily available |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15825 | 21 CFR 111.65 | Quality control - quality, dietary supplement |
| 15897 | 21 CFR 111.83(a) | Reserve sample - collect, hold |
| 16013 | 21 CFR 111.140(b)(1) | Records - quality control operations; responsibilities |
| 16042 | 21 CFR 111.503 | Written procedures - returned dietary supplement |