FDA 483 - Sandare International, Inc - November 02, 2021

Sandare Intl., Inc. in Cedar Hill, TX, a device manufacturer, was cited for significant quality system deficiencies during an FDA inspection. Observations included failures in process validation, incoming product inspection, equipment calibration, and document control. The firm also lacked adequate procedures for medical device reporting, supplier change agreements, design changes, nonconforming product, and corrective and preventive actions.