FDA 483 - Century Pharmaceuticals, Inc. - October 25, 2022

Century Pharmaceuticals, Inc. in Indianapolis, IN, was cited for multiple quality system deficiencies during an FDA inspection. The observations primarily focused on inadequate procedures for risk analysis, design change, design validation, and process validation for their medical devices. Additionally, issues were noted with corrective and preventive actions, complaint handling, and the maintenance of device master records, indicating a need for comprehensive improvements in the firm's quality management system.