FDA Inspection 1316128 — Mytosynth Nutraceuticals, LLC
The FDA completed an inspection of Mytosynth Nutraceuticals, LLC on May 7, 2026 in Jordan, MN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 13 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 7, 2026
- Fiscal Year
- 2026
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Jordan, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15727 | 21 CFR 111.365(e) | Microorganism, decomposition - remove, destroy, prevent |
| 15838 | 21 CFR 111.70(d) | Specifications - labels, packaging |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15954 | 21 CFR 111.113(a)(2) | Quality control master manufacturing record; material review, disposition |
| 22811 | 21 CFR 111.453 | Written procedures - establish; holding and distribution |
| 22840 | 21 CFR 111.35(b) | Make and keep records - equipment and utensils |
| 22843 | 21 CFR 111.70(b) | Specifications - components |
| 22847 | 21 CFR 111.70(e) | Specifications - finished dietary supplement |
| 22882 | 21 CFR 111.180(b) | Documentation - components |
| 22884 | 21 CFR 111.205(a) | Master manufacturing record - prepared |
| 22886 | 21 CFR 111.205(b)(1) | Master manufacturing record - specifications, quality; packaging, labeling |
| 22888 | 21 CFR 111.210 | Master manufacturing record - record requirements |
| 22890 | 21 CFR 111.260 | Batch record - required information |