FDA 483 - Molecular Biologicals, LLC - September 26, 2019

Molecular Biologicals, LLC, an initial importer in Pasadena, TX, was cited for multiple significant quality system deficiencies during an FDA inspection from September 10-26, 2019. The firm lacked established written procedures for medical device reporting, complaint handling, corrective and preventive actions, control and distribution of finished devices, and acceptance of incoming products. These observations indicate a fundamental absence of critical quality system controls.