483
Memorial Hospital For Cancer & Allied DiseasesMemorial Hospital For Cancer & Allied Diseases – FDA 483, May 29, 2019
Record Details
Memorial Hospital For Cancer & Allied Diseases, a blood bank in New York, was inspected by the FDA from May 13-29, 2019. The inspection revealed significant deficiencies in record-keeping, adherence to standard operating procedures, failure to investigate product deviations, and untimely reporting of biological product deviations. These issues indicate a lack of robust quality control and compliance with regulatory requirements for blood and blood component processing and distribution.
- Inspection date
- May 29, 2019
- Product type
- biologics
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ID · 9e8a38e7-c98f-43c9-a00e-b7af5b01aac5
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