Oscor Inc. – FDA 483, Feb 11, 2025

Oscor Inc., a medical device manufacturer in Palm Harbor, FL, was cited for significant deficiencies in its quality system during an FDA inspection. The firm failed to adequately establish procedures for corrective and preventive actions, resulting in the continued release of potentially defective devices. Additionally, complaint handling procedures were found to be inadequate, as the firm did not complete required health risk assessments for confirmed product defects.