FDA 483 - ManukaMed Limited Partnership - May 11, 2023

An FDA inspection of ManukaMed Limited Partnership, a manufacturer in Masterton, New Zealand, revealed significant deficiencies in their quality management system. Observations included inadequate procedures for complaint handling and environmental control, insufficient documentation of corrective and preventive actions, and a lack of auditor independence in internal quality audits. These findings suggest a need for comprehensive improvements in their operational and quality assurance processes.