FDA Inspection
Donor Center of NYBCDonor Center of NYBC – FDA Inspection, Feb 18, 2010
Record Details
This FDA Inspection record concerns Donor Center of NYBC, with an inspection on February 18, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Donor Center of NYBC
- Inspection Date
- February 18, 2010
- Product Type
- Biologics
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ID · 8c839ac4-77c0-435e-be70-85933f6f0878
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 645136
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
2- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 211.100(b)SOPs not followed / documented
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Other FDA inspections of Donor Center of NYBC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| December 18, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 3, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 5, 2012 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Donor Center of NYBC
- FDA Inspection 954285 - 2015-12-18
- FDA Inspection 883283 - 2014-06-03
- FDA Inspection 774840 - 2012-04-05
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