FDA Inspection
New York Blood Center, Inc. Donor Center of NYBCNew York Blood Center, Inc. Donor Center of NYBC – FDA Inspection, Mar 30, 2023
Record Details
This FDA Inspection record concerns New York Blood Center, Inc. Donor Center of NYBC, with an inspection on March 30, 2023, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- March 30, 2023
- Product Type
- Biologics
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ID · 3b87e3ea-bdfb-4b9f-9f11-3ed544b32ed6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1201173
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of New York Blood Center, Inc. Donor Center of NYBC
8| Date | Classification | Office | Project area |
|---|---|---|---|
| June 24, 2024 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| January 27, 2020 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 6, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 27, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 3, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for New York Blood Center, Inc. Donor Center of NYBC
- FDA Inspection 1229288 - 2024-06-24
- FDA Inspection 1118351 - 2020-01-27
- FDA Inspection 1064445 - 2018-08-06
- FDA Inspection 978130 - 2016-07-27
- FDA Inspection 902195 - 2014-11-03
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