FDA Inspection 1253912 — RegenX, LLC
The FDA completed an inspection of RegenX, LLC on November 6, 2024 in Bloomer, WI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 6, 2024
- Fiscal Year
- 2025
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Bloomer, WI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 22811 | 21 CFR 111.453 | Written procedures - establish; holding and distribution |
| 22813 | 21 CFR 111.553 | Written procedures - establish; product complaint |
| 22859 | 21 CFR 111.103 | Written procedures - establish; quality control operations |
| 22908 | 21 CFR 111.503 | Written procedures - establish; returned dietary supplements |