FDA Inspection 749273 — Nassau Health Care Corporation D/B/A/ NuHealth
The FDA completed an inspection of Nassau Health Care Corporation D/B/A/ NuHealth on Oct 5, 2011 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). 6 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 5, 2011
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- East Meadow, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 160 | 21 CFR 606.160(a)(1) | Person performing, test results, interpretation |
| 41 | 21 CFR 606.40(a)(1) | Provide space for examination |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 81 | 21 CFR 606.100(b)(2) | Donor qualifying tests & measurements |
| 93 | 21 CFR 606.100(b)(14) | QC procedures for supplies and reagents |
| 94 | 21 CFR 606.100(b)(15) | Schedules and procedures for equipment & calibration |