FDA 483 - Reach Medical Inc. - December 30, 2022

Reach Medical Inc. in Collierville, TN, a medical device manufacturer, was inspected by the FDA from December 27-30, 2022. The inspection revealed significant deficiencies across its quality system, including inadequate procedures for CAPA, quality audits, complaint handling, device history records, product identification, and equipment calibration. These findings indicate a systemic failure to establish and follow required quality control procedures.