FDA Inspection 1007869 — Nexagen, LLC
The FDA completed an inspection of Nexagen, LLC on April 7, 2017 in Fayetteville, GA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 11 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 7, 2017
- Fiscal Year
- 2017
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Fayetteville, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15578 | 21 CFR 111.155(c) | Components - quarantine |
| 15660 | 21 CFR 111.475(b)(2) | Records - product distribution |
| 15761 | 21 CFR 111.205(b)(1) | Master manufacturing record - specifications; quality |
| 15809 | 21 CFR 111.570(b)(1) | Written procedures - product complaint; review, investigate |
| 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 |
| 15891 | 21 CFR 111.80(a) | Components packaging, labels received |
| 16014 | 21 CFR 111.140(b)(1) | QC ops; written procedures; material review, disposition |
| 16057 | 21 CFR 111.535(b)(1) | Records - returned dietary supplement: written procedures |