FDA Inspection 1147466 — Stony Brook Community Medical PC - Island Fertility
The FDA completed an inspection of Stony Brook Community Medical PC - Island Fertility on July 30, 2021 in Commack, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 30, 2021
- Fiscal Year
- 2021
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Commack, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12222 | 21 CFR 1271.47(a) | Design of procedures to ensure compliance |
| 12229 | 21 CFR 1271.50(a) | Determination based on screening and testing |
| 12493 | 21 CFR 1271.90(c) | Eligibility not required--warning labels |