FDA 483 - Polar Products Inc. - August 04, 2022

Polar Products Inc., a medical device manufacturer in Stow, OH, was inspected by the FDA from July 25 to August 4, 2022, resulting in eight observations. The inspection revealed significant deficiencies across multiple quality system areas, including design controls, risk analysis, CAPA, supplier management, non-conforming product control, device history records, labeling, and quality audits. Several observations were repeats from previous inspections, indicating persistent issues.