FDA 483 - Contour Healer LLC - September 15, 2023

Contour Healer LLC, a medical device manufacturer, underwent an FDA inspection from September 11-15, 2023. The inspection identified three primary observations concerning the firm's quality management system. First, procedures for acceptance activities were found to be inadequate; specifically, there was no documented receiving, in-process, or final inspection for returned devices, and batch records lacked Certificates of Conformance. Second, the company failed to adequately establish requirements for suppliers and consultants, as evidenced by an incomplete approved supplier list. Third, management with executive responsibility did not review the quality system's suitability and effectiveness at defined intervals, with management review meetings occurring inconsistently. These observations indicate a failure to adequately define, document, and implement critical quality system requirements. Contour Healer LLC has verbally committed to correcting these issues, emphasizing the firm's responsibility to implement comprehensive corrective actions to address all noted deficiencies.