483
New York Blood Center, Inc.New York Blood Center, Inc. – FDA 483, Jun 23, 2026
Record Details
An FDA inspection of New York Blood Center, Inc. in Fishkill, NY, a donor center, revealed significant deficiencies in standard operating procedures and equipment validation. The firm failed to establish an SOP for cooler validation and did not adequately validate transport coolers used for blood products. These issues raise concerns about the proper handling and temperature control of blood components during transit.
- Office
- New York District Office
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ID · 26c63f1b-61e7-488c-9e9f-c74b5138fd97
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