FDA Inspection
New York Blood Center EnterprisesNew York Blood Center Enterprises – FDA Inspection, Aug 2, 2011
Record Details
This FDA Inspection record concerns New York Blood Center Enterprises, with an inspection on August 2, 2011, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- August 2, 2011
- Product Type
- Biologics
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ID · 2d61572a-ce26-4f2f-abbd-15a813ef6aeb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 735235
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
5- 21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 606.171Biological product deviation report
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.100(b)SOPs not followed / documented
Full citation text and observation details available on the Dashboard.
Other FDA inspections of New York Blood Center Enterprises
13| Date | Classification | Office | Project area |
|---|---|---|---|
| April 3, 2026 | Not classified | New York District Office | Blood and Blood Products |
| September 24, 2025 | VAI | New York District Office | Blood and Blood Products |
| September 7, 2023 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 11, 2020 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| August 7, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for New York Blood Center Enterprises
- FDA Inspection 1311062 - 2026-04-03
- FDA Inspection 1283668 - 2025-09-24
- FDA Inspection 1217513 - 2023-09-07
- FDA Inspection 1118178 - 2020-02-11
- FDA Inspection 1064704 - 2018-08-07
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