FDA Inspection 726235 — Gemini Pharmaceuticals, Inc.
The FDA completed an inspection of Gemini Pharmaceuticals, Inc. on June 1, 2011 in Commack, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 1, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Commack, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1918 | 21 CFR 211.166(a)(2) | Stability sample storage conditions described |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |