FDA 483 - Lingraphicare America, Inc. - February 03, 2025

An FDA inspection of Lingraphicare America, Inc. in Princeton, NJ, revealed significant deficiencies in its quality system, particularly concerning design controls, corrective and preventive actions, document control, and complaint handling. The firm failed to establish adequate procedures for design validation and review, leading to issues with software testing and release. Additionally, the inspection found a lack of proper documentation for CAPA effectiveness, approval of critical documents, and comprehensive complaint evaluation, including MDR decisions and timely reporting.