FDA 483 - Heany Industries Incorporated - March 23, 2022

An FDA inspection of Heany Industries Incorporated, a medical device manufacturer in Scottsville, NY, revealed significant deficiencies in their quality system. The firm failed to validate critical processes and software for dental zirconia products, and also exhibited inadequate procedures for corrective and preventive actions, control of nonconforming products, and management of out-of-tolerance test equipment. These issues indicate a lack of robust quality control over their manufacturing operations.