FDA Inspection 1085294 — Nexagen, LLC
The FDA completed an inspection of Nexagen, LLC on April 4, 2019 in Fayetteville, GA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 12 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 4, 2019
- Fiscal Year
- 2019
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Fayetteville, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15434 | 21 CFR 111.15(d)(2) | Pest control measures |
| 15442 | 21 CFR 111.15(b)(1) | Physical plant - clean and sanitary |
| 15478 | 21 CFR 111.20(f) | Physical plant - bulbs, fixtures, skylights |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15645 | 21 CFR 111.455(c) | Hold - mix-up, contamination, deterioration |
| 15759 | 21 CFR 111.205(b)(2) | Master manufacturing record - controls, procedures |
| 15778 | 21 CFR 111.415(b) | Dietary supplement - protect, contamination |
| 15810 | 21 CFR 111.570(b)(2) | Record - product complaint; good manufacturing practice |
| 15825 | 21 CFR 111.65 | Quality control - quality, dietary supplement |
| 15828 | 21 CFR 111.70(a) | Specifications - manufacturing process |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |