FDA Inspection 1088610 — Montefiore's Institute for Reproductive Medicine and Health
The FDA completed an inspection of Montefiore's Institute for Reproductive Medicine and Health on May 3, 2019 in Hartsdale, NY. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- May 3, 2019
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Hartsdale, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12221 | 21 CFR 1271.47(a) | Procedures for all other requirements |
| 12230 | 21 CFR 1271.50(a) | Responsible person to determine, document |