FDA 483 - Micron Medical Corporation - January 26, 2021

Micron Medical Corporation, a sponsor in Boca Raton, FL, was inspected regarding its conduct and oversight of an investigational device study. The inspection revealed significant deficiencies in the evaluation and reporting of unanticipated adverse device effects, inadequate monitoring of clinical sites, and incomplete device accountability records. Additionally, the firm failed to submit required annual progress reports to the FDA and IRBs.