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

An FDA inspection of MHC Medical Products LLC, Cincinnati, OH, was conducted from January 10 to February 2, 2018. This initial Level 1 QSIT inspection, aligned with medical device manufacturing regulations, focused on the firm's Corrective and Preventive Actions (CAPA) and Production and Processing Controls subsystems. The inspection resulted in a 6-item FDA Form 483, detailing significant observations. Key issues included inadequate review and evaluation of complaints for Medical Device Report (MDR) reportability (21 CFR 820.198(d)), particularly concerning potential serious injuries. The firm also lacked established procedures for complaint handling, CAPA, and finished device acceptance. Further deficiencies involved undocumented quality audits and insufficient records for approved contractors and consultants. Discussion items revealed the absence of defined CAPA inputs, a lack of current risk analysis, unvalidated in-house complaint software, and the absence of quality agreements with suppliers. Management, led by CEO Dennis B. Smith, committed to taking voluntary actions to address and correct all identified deficiencies, aiming to achieve full compliance with regulatory standards.