FDA 483 - Biosensics LLC - February 09, 2026

BioSensics LLC, a medical device manufacturer in Newton, MA, received a Form FDA 483 with three observations. The inspection revealed significant deficiencies in design control documentation for their LEGSys system, a failure to implement adequate corrective actions for recurring product nonconformities, and inadequate control of nonconforming products. These issues indicate a lack of adherence to quality system requirements.