FDA 483 - Biomet, Inc. - April 24, 2018

An FDA inspection conducted from April 9 to April 24, 2018, identified ten significant violations at Zimmer Biomet, Inc., a medical device manufacturer located in Warsaw, Indiana. Many of these issues were repeat observations from a previous inspection, indicating persistent systemic failures in their quality management system. The primary concerns revolve around the inadequacy of corrective and preventive actions (CAPA). The company failed to implement effective measures to prevent recurring bacterial endotoxin failures in polyethylene devices, with manual cleaning processes lacking proper validation and studies failing to provide objective evidence of product safety. Furthermore, CAPAs related to cleaning validations were not commensurate with risk, and products were distributed without adequately validated cleaning processes. Design History Files exhibited numerous deficiencies, including ambiguous inputs, insufficient verification, and inadequate risk analysis that failed to consider all high-risk failure modes. Other critical observations included inadequate validation of sterilization processes, inconsistencies in risk analysis, and insufficient controls over purchased services, specifically contract lab testing methods. Environmental control procedures were found lacking, with insufficient investigation into microbial excursions and employees violating cleanroom practices. The firm also demonstrated inconsistent procedures for controlling nonconforming products and for establishing acceptance criteria in packaging. Finally, a significant deficiency in employee training was noted, with operators unable to identify relevant procedures, correctly measure parts, or properly execute tasks. These observations highlight non-compliance with the FDA's Quality System Regulation for medical devices, particularly concerning process validation, design controls, risk management, and training. Zimmer Biomet is required to implement comprehensive corrective actions to address these systemic issues, ensuring product quality, safety, and regulatory adherence.