FDA Inspection
Nassau Health Care Corporation d/b/a/ NuHealthNassau Health Care Corporation d/b/a/ NuHealth – FDA Inspection, Apr 8, 2016
Record Details
This FDA Inspection record concerns Nassau Health Care Corporation d/b/a/ NuHealth, with an inspection on April 8, 2016, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- April 8, 2016
- Product Type
- Biologics
View Company Profile
ID · ae0e3580-0353-45a1-9289-06aad8f4f869
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 967291
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
9- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 600.10(b)Personnel capabilities
- 21 CFR 630.40(c)Notification w/in 8 weeks
- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 606.171Biological product deviation report
- 21 CFR 606.160(a)(1)Legibility and indelibility
- 21 CFR 600.12(a)Maintenance - tracing
- 21 CFR 600.11(a)Work areas
- 21 CFR 211.100(b)SOPs not followed / documented
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Nassau Health Care Corporation d/b/a/ NuHealth
5| Date | Classification | Office | Project area |
|---|---|---|---|
| September 19, 2022 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 22, 2018 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 25, 2013 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| October 5, 2011 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 16, 2010 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Nassau Health Care Corporation d/b/a/ NuHealth
- FDA Inspection 1179788 - 2022-09-19
- FDA Inspection 1042421 - 2018-02-22
- FDA Inspection 856795 - 2013-11-25
- FDA Inspection 749273 - 2011-10-05
- FDA Inspection 645399 - 2010-02-16
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