FDA Inspection 735124 — Long Island Jewish Medical Center
The FDA completed an inspection of Long Island Jewish Medical Center on Aug 2, 2011 in New Hyde Park, 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). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 2, 2011
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- New Hyde Park, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |