FDA Inspection
Donor Center of NYBCDonor Center of NYBC – FDA Inspection, Apr 5, 2012
Record Details
This FDA Inspection record concerns Donor Center of NYBC, with an inspection on April 5, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Donor Center of NYBC
- Inspection Date
- April 5, 2012
- Product Type
- Biologics
View Company Profile
ID · 65498264-96c2-4f76-8e09-f614bf02f163
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 774840
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 820.75(c)Process changes - review, evaluation and revalidation
- 21 CFR 606.40Clean & orderly
- 21 CFR 820.120(a)Remain legible
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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 |
| February 18, 2010 | 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 645136 - 2010-02-18
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