Cerus Corporation – FDA EIR, Dec 15, 2015

An FDA comprehensive surveillance inspection of Cerus Corporation's Concord, CA facility was conducted from December 9-15, 2015. The inspection, based on Medical Device Quality System Inspection Technique (QSIT) and Compliance Program Guidance Manual 7382.845, focused on Management Control, Design Control, Corrective and Preventive Action (CAPA), and Production and Process Control subsystems. Upon inspection closeout, a Form FDA 483 was issued, citing a significant observation: procedures for corrective and preventive actions (CAPA) were not adequately established, specifically lacking requirements for verification or validation of all CAPA effectiveness. This was evidenced by three out of ten reviewed CAPA records missing effectiveness verification. Additionally, one CAPA record lacked an investigation, and two records lacked documented corrective/preventive actions, violating 21 CFR 820.100(a). Other issues discussed with management included inadequate descriptions of design input and output in design control procedures, and a customer complaint that was not investigated without documented justification. Cerus Corporation's management "Promised to Correct" the cited observation and was advised to submit a formal response within 15 business days. The FDA also highlighted potential legal sanctions for uncorrected serious conditions.