FDA Inspection 1246381 — Xymogen Manufacturing
The FDA completed an inspection of Xymogen Manufacturing on August 13, 2024 in Orlando, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 13, 2024
- Fiscal Year
- 2024
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Orlando, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15681 | 21 CFR 111.315(d) | Standard reference materials; criteria for selecting |
| 15696 | 21 CFR 111.315(e) | Examination, testing; established criteria |
| 15702 | 21 CFR 111.320(b) | Examination, testing; scientifically valid |
| 15875 | 21 CFR 111.75(d)(1) | Documentation specifications met; exempted, periodic testing |
| 22843 | 21 CFR 111.70(b) | Specifications - components |
| 22847 | 21 CFR 111.70(e) | Specifications - finished dietary supplement |
| 22884 | 21 CFR 111.205(a) | Master manufacturing record - prepared |
| 22888 | 21 CFR 111.210 | Master manufacturing record - record requirements |