FDA Inspection 967291 — Nassau Health Care Corporation D/B/A/ NuHealth
The FDA completed an inspection of Nassau Health Care Corporation D/B/A/ NuHealth on Apr 8, 2016 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). 9 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 8, 2016
- Fiscal Year
- 2016
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- East Meadow, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 159 | 21 CFR 606.160(a)(1) | Legibility and indelibility |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 9044 | 21 CFR 600.10(b) | Personnel capabilities |
| 9050 | 21 CFR 600.11(a) | Work areas |
| 9078 | 21 CFR 600.12(a) | Maintenance - tracing |
| 9225 | 21 CFR 606.171 | Biological product deviation report |
| 9234 | 21 CFR 630.40(c) | Notification w/in 8 weeks |
| 98 | 21 CFR 606.100(c) | Thorough investigations |