FDA EIR - bioMerieux SA - February 09, 2017

An FDA routine inspection of BioMerieux SA, a manufacturer of Class II in-vitro diagnostic Etest devices, was conducted from February 6-9, 2017, in La Balme Les Grottes, France. The QSIT Level II inspection, conducted under compliance program 7382.845, covered management, design, corrective and preventive actions (CAPA), and production controls. Although the inspection did not result in an FDA Form 483, several concerns were discussed with management. The firm had three recent Etest product recalls since 2015, including a Class I recall for false susceptibility and another for stability issues. While a previous FDA 483 observation regarding inadequate CAPA documentation from 2013 was corrected, the current inspection highlighted areas for improvement. These included insufficient supplier controls, specifically concerning the clear identification of antibiotic manufacturers and verification of their quality systems. Furthermore, a CAPA addressing a false susceptibility recall was closed without documented verification of effectiveness. The firm also struggled to identify the root cause for incorrect MIC specifications in Etest MX32 products and had released an Etest Oxacillin lot with a technical justification despite failed supplementary testing, which subsequently led to new complaints and a pending health hazard evaluation for a potential field action. The FDA advised the firm to strengthen supplier quality criteria and ensure comprehensive root cause analyses and effectiveness verification for all corrective actions.