FDA 483 - Focus Medical, LLC - May 02, 2025

Focus Medical, LLC, a medical device manufacturer in Bethel, CT, was inspected by the FDA and received a Form 483 with eight observations. The inspection revealed significant deficiencies primarily related to process controls, device history records, labeling, calibration procedures, and complaint investigations for their CO2 and other laser systems. These issues indicate a lack of adherence to quality system regulations for medical devices.