FDA Inspection
Nassau Health Care Corporation d/b/a/ NuHealthNassau Health Care Corporation d/b/a/ NuHealth – FDA Inspection, Oct 5, 2011
Record Details
This FDA Inspection record concerns Nassau Health Care Corporation d/b/a/ NuHealth, with an inspection on October 5, 2011, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- October 5, 2011
- Product Type
- Biologics
View Company Profile
ID · 5ba9a536-fc81-4c0c-9a61-f226b7d383f0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 749273
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
6- 21 CFR 606.40(a)(1)Provide space for examination
- 21 CFR 606.160(a)(1)Person performing, test results, interpretation
- 21 CFR 606.100(b)(15)Schedules and procedures for equipment & calibration
- 21 CFR 606.100(b)(14)QC procedures for supplies and reagents
- 21 CFR 606.100(b)(2)Donor qualifying tests & measurements
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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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 |
| 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 |
| 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 967291 - 2016-04-08
- FDA Inspection 856795 - 2013-11-25
- FDA Inspection 645399 - 2010-02-16
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