FDA Inspection 1062808 — Maimonides Medical Center
The FDA completed an inspection of Maimonides Medical Center on Aug 20, 2018 in Brooklyn, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 20, 2018
- Fiscal Year
- 2018
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Brooklyn, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 144 | 21 CFR 606.140(c) | Adequate identification and handling of test samples |
| 154 | 21 CFR 606.160(a)(1) | Concurrent documentation |
| 241 | 21 CFR 640.11(b) | General requirements - inspection |
| 251 | 21 CFR 640.25(b) | Quality control |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |