FDA 483 - MHC Medical Products LLC - February 02, 2018

An FDA inspection of MHC Medical Products LLC in Cincinnati, OH, a specification developer and complaint file establishment, revealed significant deficiencies in its quality system. The firm failed to adequately manage complaints, including MDR reportability and investigations, and lacked established procedures for corrective actions, finished device acceptance, and documentation of quality audits and approved suppliers. These findings indicate systemic issues in maintaining a compliant quality management system.