FDA Inspection 1254995 — Chelsea Fertility NYC
The FDA completed an inspection of Chelsea Fertility NYC on November 22, 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 22, 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 |
|---|---|---|
| 12229 | 21 CFR 1271.50(a) | Determination based on screening and testing |
| 12247 | 21 CFR 1271.55(d)(2) | Accurate, indelible, legible |
| 12255 | 21 CFR 1271.60(c) | Shipped but not kept in quarantine |
| 12286 | 21 CFR 1271.80(b) | Specimen collections not timely |