FDA 483 - Perahealth Inc - January 30, 2020

Perahealth Inc, a medical device software manufacturer in Charlotte, NC, was inspected by the FDA, resulting in 14 observations. The inspection revealed significant deficiencies across its quality system, including a lack of design plans, inadequate design validation documentation, missing MDR procedures, and widespread issues with document control, training, and management review processes. These findings indicate a fundamental lack of established and maintained quality system procedures.