FDA 483 - ManukaMed Limited Partnership - May 11, 2023

An FDA inspection of ManukaMed Limited Partnership, a manufacturing facility in Masterton, New Zealand, was conducted from May 8-11, 2023. The inspection resulted in a Form FDA 483, outlining four significant observations related to the company's quality management system and adherence to regulatory requirements. Key issues included inadequate procedures for receiving, reviewing, and evaluating complaints, as well as insufficient controls for environmental conditions within the facility. Additionally, documentation for corrective and preventive action (CAPA) activities and their outcomes was found to be deficient. A critical observation noted a lack of auditor independence in the firm's internal audit practices, with individuals responsible for quality audits also having direct responsibility for the matters being audited. These observations highlight areas where ManukaMed Limited Partnership must strengthen its operational and quality control processes. The company has indicated a commitment to addressing and correcting each of these identified deficiencies to ensure compliance with FDA regulations.