FDA 483 - Merits Health Products, Inc. - December 06, 2022

Merits Health Products, Inc. in Fort Myers, FL, an importer and contract manufacturer, was cited for multiple quality system deficiencies during an FDA inspection. The inspection revealed inadequate procedures for corrective and preventive actions, control of nonconforming products, complaint handling, supplier evaluation, and labeling activities. These issues indicate significant gaps in the firm's quality management system.