Medscience Research Group Inc – FDA 483, Aug 26, 2022

Medscience Research Group Inc. in West Palm Beach, FL, was issued a Form FDA 483 with five observations, all of which were repeat observations from a previous inspection in 2016. The inspection revealed significant deficiencies in the firm's quality system, including failures to establish and follow procedures for design control, supplier management, acceptance activities, corrective and preventive actions, and quality audits. These issues indicate a systemic lack of adherence to quality system regulations for medical device manufacturing.