FDA Inspection
New York Blood Center EnterprisesNew York Blood Center Enterprises – FDA Inspection, Oct 29, 2013
Record Details
This FDA Inspection record concerns New York Blood Center Enterprises, with an inspection on October 29, 2013, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- October 29, 2013
- Product Type
- Biologics
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ID · 71272cf5-9b00-4273-bbf7-dd681f1bc32f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 853530
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
7- 21 CFR 606.60(b)Equipment calibration frequency
- 21 CFR 606.160(b)Required records
- 21 CFR 600.14(a)(1)Who must report - manufacturer
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.194(a)(8)Second person sign off
- 21 CFR 606.160(a)(1)Concurrent documentation
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of New York Blood Center Enterprises
6| Date | Classification | Office | Project area |
|---|---|---|---|
| July 8, 2026 | Not classified | New York District Office | Blood and Blood Products |
| October 27, 2023 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 25, 2019 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 22, 2016 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 1, 2011 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
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