FDA Inspection 713752 — Northwell Health Laboratories
The FDA completed an inspection of Northwell Health Laboratories on Mar 28, 2011 in Little Neck, 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
- Mar 28, 2011
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Little Neck, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12399 | 21 CFR 1271.230(a) | Process validation procedures |
| 12437 | 21 CFR 1271.270(a) | Records incomplete |