MHC Medical Products LLCSeptember 23, 2022

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

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Record Details

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.

Company: MHC Medical Products LLC
Inspection Date: September 23, 2022
Product Type: Device
Office: Cincinnati District Office
Person: Teresa Kastner (Consumer Safety Officer, Medical Device Specialist)

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ID · 7cd8a9f6-c229-4961-9de3-f5354e35344e