FDA Inspection 1014930 — DYNAMIC TECHNICAL FORMULATIONS LLC
The FDA completed an inspection of DYNAMIC TECHNICAL FORMULATIONS LLC on June 16, 2017 in Alpharetta, GA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 14 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 16, 2017
- Fiscal Year
- 2017
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Alpharetta, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15388 | 21 CFR 111.10(b) | Personnel - hygienic practices |
| 15402 | 21 CFR 111.12 | Personnel - quality control personnel - qualified |
| 15410 | 21 CFR 111.14(b)(2) | Personnel - records - training |
| 15491 | 21 CFR 111.25 | Equipment - procedures |
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15583 | 21 CFR 111.155(d)(1) | Components - identify lot received |
| 15649 | 21 CFR 111.465(a)(1) | Hold - reserve samples; ordinary storage |
| 15728 | 21 CFR 111.365(d) | Chemical, microbiological, other test-contaminated components |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15796 | 21 CFR 111.430(b) | Records - packaging, labeling operations |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15828 | 21 CFR 111.70(a) | Specifications - manufacturing process |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15932 | 21 CFR 111.105(a) | Quality control - processes, specifications, written procedures |