PB&M BRANDS, LLC – FDA 483, Mar 8, 2022

PB&M BRANDS, LLC, a medical device importer in Sarasota, FL, received a Form FDA-483 with five observations during an inspection. The firm was cited for a complete lack of established quality system procedures, including those for quality policy, corrective and preventive actions, complaint handling, medical device reporting, and purchasing controls for examination gloves. These deficiencies indicate significant gaps in their quality management system for imported medical devices.