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Fischer Analysen Instrumente Gmbh, a German manufacturer of the PyloPlus UBT System 13/12CO2 breathing gas analyzer (a diagnostic medical device), failed to comply with FDA's Current Good Manufacturing Practice requirements under 21 CFR Part 820. During a November 2022 inspection, the FDA identified inadequate documentation of device software validation, including missing software revision plans and undocumented input specification requirements for software revision 1.49. These deficiencies rendered the devices adulterated and non-compliant with quality system regulations governing medical device manufacturing and controls.