FDA 483 - Integrity Medical Devices Inc. - January 08, 2024

An FDA inspection of Integrity Medical Devices Inc. in Hammonton, NJ, from October 2023 to January 2024, revealed significant deficiencies in the firm's process validation and monitoring. The company failed to adequately establish monitoring for its validated package sealing process for sterile products and did not fully validate its bottle tamper seal process, raising concerns about product quality and integrity.