FDA Inspection 782603 — Dynamic Pharmaceuticals, Inc.
The FDA completed an inspection of Dynamic Pharmaceuticals, Inc. on May 3, 2012 in Brooksville, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 11 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 3, 2012
- Fiscal Year
- 2012
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Brooksville, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15491 | 21 CFR 111.25 | Equipment - procedures |
| 15525 | 21 CFR 111.30(b) | Equipment - automated - suitability |
| 15529 | 21 CFR 111.30(e) | Equipment - controls, intended use |
| 15570 | 21 CFR 111.153 | Written procedures - components |
| 15744 | 21 CFR 111.210(h)(2) | Master manufacturing record - sampling, tests, examinations |
| 15747 | 21 CFR 111.210(g) | Packaging description, representative label |
| 15790 | 21 CFR 111.403 | Written procedures - labeling operations |
| 15886 | 21 CFR 111.77(b) | Specifications not met - identity; component, reject |
| 15953 | 21 CFR 111.113(a)(1) | Quality control production, process control; material review, disposition |
| 2205 | 21 CFR 211.186(b)(9) | Manufacturing Instructions and Specifications |
| 4400 | 21 CFR 211.186(b)(8) | Description of containers, labels, et. al. |