BIALEXDecember 17, 2018

FDA 483 - BIALEX - December 17, 2018

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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.

Company: BIALEX
Inspection Date: December 17, 2018
Product Type: Device
Office: Division of Pharmaceutical Quality Operations IV
Person: Charles L. Larson (investigator)

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