483
Meriter Health EnterprisesFDA 483 - Meriter Health Enterprises - May 07, 2025
Record Details
An FDA inspection of Meriter Health Enterprises' Blood Bank in Madison, WI, revealed significant deficiencies in establishing and following scientifically sound procedures for blood component preparation and distribution. The inspection also identified failures in maintaining adequate quality control and general records, indicating a moderate level of non-compliance with regulations critical for ensuring the safety and quality of blood products.
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ID · 73fdd1e0-3d9a-4b20-9177-43a914699d69