FDA 483 - MHC Medical Products LLC - September 23, 2022

An FDA inspection of MHC Medical Products LLC, a device specification developer in Fairfield, OH, revealed a significant issue with their design history files. The firm lacked proper documentation for the design of their safety pen needle, including design inputs, reviews, and verification/validation testing, as required by 21 CFR 820. These essential files, though reportedly maintained by a contract manufacturer, were not readily accessible or retrievable by MHC.