FDA Inspection 1273890 — Gryphus Diagnostics LLC
The FDA completed an inspection of Gryphus Diagnostics LLC on Jun 16, 2025 in Knoxville, TN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 16, 2025
- Fiscal Year
- 2025
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Knoxville, TN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 22843 | 21 CFR 111.70(b) | Specifications - components |
| 22847 | 21 CFR 111.70(e) | Specifications - finished dietary supplement |
| 22859 | 21 CFR 111.103 | Written procedures - establish; quality control operations |
| 22888 | 21 CFR 111.210 | Master manufacturing record - record requirements |