483
BIALEXFDA 483 - BIALEX - December 17, 2018
Record Details
BIALEX, a medical device manufacturer in Tucson, AZ, was cited for a significant deficiency in its quality system related to external controls. The firm failed to establish procedures to ensure that all purchased or received products and services conform to specified requirements. Specifically, BIALEX has not evaluated current suppliers according to established procedures.
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