FDA 483 - Kent Elastomer Products Inc - October 16, 2025

During an inspection conducted by the U.S. Food and Drug Administration (FDA) from October 14-16, 2025, Kent Elastomer Products Inc, a contract medical device manufacturer in Kent, OH, received a Form FDA 483. This document detailed significant observations indicating potential non-compliance with regulatory quality system requirements, likely under the Federal Food, Drug, and Cosmetic Act. The primary issues identified centered on three key areas. Firstly, procedures for corrective and preventive actions were deemed inadequate, lacking explicit data sources for triggers and clear definitions for verification and effectiveness activities. Secondly, the firm's procedures for ensuring purchased products and services conform to specified requirements were insufficient, failing to adequately address supplier monitoring, performance evaluation, risk categorization, or integration of supplier issues into the corrective action process. Lastly, procedures for monitoring and controlling validated process parameters were not adequately established. The process validation protocol did not specify which processes require validation, how statistical methods are utilized, when revalidation is necessary, or comprehensive documentation and approval requirements. Kent Elastomer Products Inc is now required to address these observations by implementing comprehensive corrective actions to ensure its quality management system aligns with regulatory expectations for medical device manufacturing.