# New York Blood Center, Inc. – FDA 483, Jun 23, 2026

Source: https://www.keypedia.com/records/483/new-york-blood-center-inc/26c63f1b-61e7-488c-9e9f-c74b5138fd97

> FDA 483 for New York Blood Center, Inc. on June 23, 2026. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: New York Blood Center, Inc.
- Inspection Date: 2026-06-23
- Product Type: biologics
- Office Name: New York District Office
- Summary: 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.

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