FDA Inspection 862451 — Long Island Jewish Medical Center
The FDA completed an inspection of Long Island Jewish Medical Center on Jan 16, 2014 in New Hyde Park, NY. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 5 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Jan 16, 2014
- Fiscal Year
- 2014
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- New Hyde Park, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 154 | 21 CFR 606.160(a)(1) | Concurrent documentation |
| 4412 | 21 CFR 211.194(a)(7) | Signatures and dates--person who performs test |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 9086 | 21 CFR 600.14(a)(1) | Who must report - manufacturer |