FDA Inspection
Nassau Health Care Corporation d/b/a/ NuHealthNassau Health Care Corporation d/b/a/ NuHealth – FDA Inspection, Feb 22, 2018
Record Details
This FDA Inspection record concerns Nassau Health Care Corporation d/b/a/ NuHealth, with an inspection on February 22, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- February 22, 2018
- Product Type
- Biologics
View Company Profile
ID · 94847c1f-ed55-47e8-8920-2c04a166bd6d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1042421
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 600.12(a)Maintenance - concurrence
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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 |
| April 8, 2016 | 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 967291 - 2016-04-08
- FDA Inspection 856795 - 2013-11-25
- FDA Inspection 749273 - 2011-10-05
- FDA Inspection 645399 - 2010-02-16
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.