FDA Inspection 1044504 — Nexagen, LLC
The FDA completed an inspection of Nexagen, LLC on March 16, 2018 in Fayetteville, GA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 12 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 16, 2018
- Fiscal Year
- 2018
- 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 |
| 15447 | 21 CFR 111.15(c)(3) | Cleaning compounds and toxic materials - holding |
| 15450 | 21 CFR 111.15(f)(3) | Plumbing - source of contamination |
| 15478 | 21 CFR 111.20(f) | Physical plant - bulbs, fixtures, skylights |
| 15499 | 21 CFR 111.27(a) | Equipment - design - suitable |
| 15505 | 21 CFR 111.27(a)(3)(v) | Equipment - protect from contamination |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15645 | 21 CFR 111.455(c) | Hold - mix-up, contamination, deterioration |
| 15650 | 21 CFR 111.465(a) | Hold - reserve samples; contamination, deterioration |
| 15759 | 21 CFR 111.205(b)(2) | Master manufacturing record - controls, procedures |
| 15778 | 21 CFR 111.415(b) | Dietary supplement - protect, contamination |