FDA 483 - STERITECH, INC. - February 10, 2021

STERITECH, INC., a contract sterilization facility in Salinas, PR, was inspected by the FDA from February 3-10, 2021. The inspection revealed significant deficiencies in the firm's corrective and preventive action (CAPA) system, including a lack of established procedures and inadequate documentation of CAPA activities and effectiveness checks. Additionally, production processes were not consistently monitored to ensure devices conformed to specifications, with temperature deviations noted during batch record reviews.