Chemence Medical Products, Inc. – FDA 483, Feb 23, 2018

An FDA inspection of Chemence Medical Products, Inc. in Alpharetta, GA, revealed significant deficiencies across four observations related to quality system procedures. The firm failed to adequately establish procedures for acceptance activities, process revalidation, equipment calibration, and rework of nonconforming products. These issues indicate a lack of robust quality control and documentation practices.