Alltech Medical Systems America Inc – FDA 483, Jul 29, 2019

Alltech Medical Systems America Inc, a medical device manufacturer in Solon, OH, was inspected by the FDA. The inspection revealed significant deficiencies across multiple quality system areas, including inadequate procedures for corrective and preventive actions, complaint handling, servicing activities, nonconforming product control, supplier management, and design verification and validation. These issues indicate a systemic lack of robust quality management practices.