C.R. Bard, Inc. – FDA Warning Letter, Feb 13, 2008

An FDA inspection of C.R. Bard Inc.'s Humacao, Puerto Rico facility (Nov 2007 - Feb 2008) found its medical devices adulterated, non-compliant with Quality System (QS) regulation (21 CFR Part 820). The firm's responses were largely inadequate. Key violations included: failure to establish product identification procedures (21 CFR § 820.60), causing product mix-ups; failure to control nonconforming product (21 CFR § 820.90(a)), leading to distributed mislabeled devices; failure to identify and implement effective corrective and preventive actions (CAPA) (21 CFR § 820.100(a)(3)) for recurring quality issues, and not extending investigations to distributed products; failure to implement and evaluate CAPA changes (21 CFR § 820.100(a)(5)), resulting in repeated CAPA failures and inconsistent market withdrawals; failure to retain required manufacturing records (21 CFR § 820.180(b)); failure to establish and timely process complaints (21 CFR § 820.198(a)), including inadequate CAPA initiation and incomplete investigations; failure to conduct timely quality audits (21 CFR § 820.22); and management's failure to ensure an adequate and effective quality system (21 CFR § 820.20). The FDA expressed serious concerns regarding root cause determination, distributed product investigations, and mislabeling criticality. The firm proposed corporate involvement and additional QA resources. Prompt correction within 15 working days is required to avoid regulatory actions like seizure, injunction, civil money penalties, and impacts on premarket approvals or foreign government certificates.