FDA 483 - Inspirx, Inc. - March 11, 2019

Inspirx, Inc. in Somerset, NJ was cited during an FDA inspection from March 5-11, 2019, for significant deficiencies in its complaint handling system for medical devices. The firm failed to adequately review, evaluate, and investigate complaints, often closing them prematurely without complete investigations from contract manufacturers. Additionally, complaint files lacked documented test results for functional testing.