FDA Inspection 1317530 — Gemini Pharmaceuticals, Inc.
The FDA completed an inspection of Gemini Pharmaceuticals, Inc. on May 15, 2026 in Commack, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 15, 2026
- Fiscal Year
- 2026
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Commack, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15681 | 21 CFR 111.315(d) | Standard reference materials; criteria for selecting |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 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 |
| 22890 | 21 CFR 111.260 | Batch record - required information |
| 22894 | 21 CFR 111.315(b) | Sampling plans; establish, follow |