FDA Inspection
Nassau Health Care Corporation d/b/a/ NuHealthNassau Health Care Corporation d/b/a/ NuHealth – FDA Inspection, Nov 25, 2013
Record Details
This FDA Inspection record concerns Nassau Health Care Corporation d/b/a/ NuHealth, with an inspection on November 25, 2013, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- November 25, 2013
- Product Type
- Biologics
View Company Profile
ID · 63d4dc27-8849-4b86-a8fe-4306d66173d5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 856795
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
7- 21 CFR 606.160(a)(2)Determination of lot numbers and supplies
- 21 CFR 606.160(b)Required records
- 21 CFR 606.100(b)Written SOPs available for use by personnel
- 21 CFR 606.160(a)(1)Legibility and indelibility
- 21 CFR 606.160(a)(1)Concurrent documentation
- 21 CFR 606.160(a)(1)Person performing, test results, interpretation
- 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 |
| 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 967291 - 2016-04-08
- FDA Inspection 749273 - 2011-10-05
- FDA Inspection 645399 - 2010-02-16
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