New York Blood Center IncFebruary 24, 2021

FDA 483 - New York Blood Center Inc - February 24, 2021

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Record Details

New York Blood Center Inc, a donor center in Massapequa, NY, was inspected and cited for three observations related to quality system deficiencies. The inspection revealed issues with the availability and adherence to written standard operating procedures for blood collection, as well as failures in the standardization and calibration of equipment. These findings indicate a need for improved procedural control and equipment maintenance at the facility.

Company: New York Blood Center Inc
Inspection Date: February 24, 2021
Product Type: Biologics
Office: Division of Human and Animal Food Operations - East I
Person: Irina Gaberman (Investigator)

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ID · 46a7dfcb-fdde-4e76-8556-ca7167ebde3a