MIM Software Inc – FDA EIR, Mar 27, 2015

A US Food and Drug Administration (FDA) inspection of MIM Software Inc., a medical imaging software manufacturer located in Cleveland, OH, was conducted from March 10 to March 27, 2015. This QSIT Level II inspection, guided by regulatory frameworks such as 21 CFR 820 and 21 CFR 806, focused on the company's Quality System, specifically Management, Design, Corrective and Preventive Action (CAPA), and Production & Process Controls. The inspection resulted in five significant observations documented on an FDA-483 form. Key issues included the company's failure to provide documented justification for not reporting two field corrections and removals. Additionally, there were inadequate procedures for design validation, lacking protocols for external site testing and assurance of user needs. Its risk analysis process was deemed insufficient, with post-market data from safety-priority complaints not consistently used to update hazard, severity, or probability assessments. Procedures for design changes also lacked clear documentation regarding the need for new 510(k) submissions for software releases. Finally, CAPA procedures were not adequately established, with deficiencies in quality data trending, unclear definitions of non-conformances, and a failure to determine the root cause of misclassified customer feedback events. MIM Software Inc. management acknowledged the findings, promising to correct each observation and implement necessary updates to their quality system procedures. A written response was submitted to the FDA.