FDA Inspection 1041525 — Gemini Pharmaceuticals, Inc.
The FDA completed an inspection of Gemini Pharmaceuticals, Inc. on February 16, 2018 in Commack, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 16, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Commack, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1194 | 21 CFR 211.42(c) | Defined areas of adequate size for operations |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 4306 | 21 CFR 211.80(a) | Written Procedures Not Followed |
| 4328 | 21 CFR 211.122(a) | Written procedures not followed |