FDA Inspection 1253848 — Manhattan Fertility Services LLC
The FDA completed an inspection of Manhattan Fertility Services LLC on November 5, 2024 in New York, 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: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 5, 2024
- Fiscal Year
- 2025
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- New York, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12213 | 21 CFR 1271.47(a) | Testing, screening, donor eligibility procedures |
| 12229 | 21 CFR 1271.50(a) | Determination based on screening and testing |
| 12247 | 21 CFR 1271.55(d)(2) | Accurate, indelible, legible |
| 12271 | 21 CFR 1271.65(b)(2) | Prominently labeled (limited use) |