Centurion Medical Products, LP – FDA 483, Aug 20, 2019

Centurion Medical Products Corporation, a medical device manufacturer in Howell, MI, was cited for multiple quality system deficiencies during an FDA inspection. Observations included inadequate environmental controls, insufficient validation of sterile kit sealing processes and production software, and poorly established procedures for package seal acceptance and corrective and preventive actions. These issues indicate a moderate level of non-compliance with quality system regulations.