FDA Inspection 895464 — Manhattan Reproductive Medicine, PC
The FDA completed an inspection of Manhattan Reproductive Medicine, PC on September 18, 2014 in New York, NY. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 5 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 18, 2014
- Fiscal Year
- 2014
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- New York, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12230 | 21 CFR 1271.50(a) | Responsible person to determine, document |
| 12247 | 21 CFR 1271.55(d)(2) | Accurate, indelible, legible |
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |
| 12278 | 21 CFR 1271.75(a)(2) | Risks associated with xenotransplantation |
| 12287 | 21 CFR 1271.80(c) | Kits not FDA approved, specifically labeled |