FDA Inspection 645399 — Nassau Health Care Corporation D/B/A/ NuHealth
The FDA completed an inspection of Nassau Health Care Corporation D/B/A/ NuHealth on Feb 16, 2010 in East Meadow, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 16, 2010
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- East Meadow, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |