FDA 483 - Primus Corporation dba Trinity Biotech - February 06, 2020

Primus Corporation, a medical device manufacturer in Kansas City, MO, was cited for significant deficiencies in its quality system. Observations included a lack of records for non-reportable correction and removal actions, an inadequate risk analysis procedure that was not properly implemented, and an incomplete design history file lacking required verifications and validations. These issues indicate systemic problems with the firm's quality management and design control processes.