FDA Inspection 700726 — Dynamic Pharmaceuticals, Inc.
The FDA completed an inspection of Dynamic Pharmaceuticals, Inc. on December 3, 2010 in Brooksville, 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
- December 3, 2010
- Fiscal Year
- 2011
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Brooksville, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15492 | 21 CFR 111.25(a) | Procedures - calibrating instruments |
| 15534 | 21 CFR 111.255(c) | Batch record - each step |
| 15548 | 21 CFR 111.260(h) | Batch record - results; testing, examination; batch |
| 15550 | 21 CFR 111.260(j) | Batch record - manufacture |
| 15683 | 21 CFR 111.315(c) | Examination, testing methods; criteria for selecting |
| 15723 | 21 CFR 111.365(i) | Metal, foreign material |
| 15743 | 21 CFR 111.210(h)(3) | Master manufacturing record - specific actions; quality |
| 15834 | 21 CFR 111.70(c)(2) | Specifications identity, purity strength, composition |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |