FDA Inspection 918290 — Westchester IVF
The FDA completed an inspection of Westchester IVF on February 19, 2015 in White Plains, 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
- February 19, 2015
- Fiscal Year
- 2015
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- White Plains, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12229 | 21 CFR 1271.50(a) | Determination based on screening and testing |
| 12242 | 21 CFR 1271.55(c) | Name and personal info on accompanying records |
| 12496 | 21 CFR 1271.85(b)(2) | SOP for release; reactive for CMV |