The Metrix Company’s failure to report potentially serious device malfunctions earned the Dubuque, Iowa manufacturer a Form 483.

During the agency’s April 22-25 inspection of the site, it noted deficiencies regarding the firm’s MDRs for sterilized ethylene-vinyl acetate (EVA) dual-chamber containers. The Class II medical devices were cited in seven MDR reports submitted by a contract customer; the firm failed to alert the FDA to these device failures.

The firm also failed to report an additional five EVA dual-chamber container failures, a repeat observation from a 2016 inspection.