FDA 483 - Wesley Coe (Cambridge) Ltd. - June 30, 2023

This FDA Form 483 was issued to Medevice Systems following an inspection conducted from January 14 to January 15, 2015. The inspection revealed significant observations related to the company's Quality System, specifically concerning environmental controls for its manufacturing processes. The primary violation noted was the inadequacy of established procedures for controlling environmental conditions within the firm

’s facility. More specifically, the clean room procedures were found to lack adequate definitions for controlling airborne particulate concentration levels. This suggests a potential non-compliance with the Quality System Regulation, particularly requirements related to environmental control and maintaining product quality and safety, as outlined in the Federal Food, Drug, and Cosmetic Act. While the FDA 483 itself is not a final determination of non-compliance, it indicates conditions that may violate FDA requirements. Medevice Systems is responsible for conducting internal self-audits to identify and correct all identified violations of Quality System requirements. The company is expected to provide a comprehensive response detailing its corrective actions and a timeline for their implementation to address these observations.