# FDA 483 - ManukaMed Limited Partnership - May 11, 2023

Source: https://www.keypedia.com/records/483/manukamed-limited-partnership/7e22d8e5-d03a-46c9-8843-092558341265

> FDA 483 for ManukaMed Limited Partnership on May 11, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ManukaMed Limited Partnership
- Inspection Date: 2023-05-11
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: 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.

## Related Officers

- [investigator](https://www.keypedia.com/people/john-a-sciacchitano/9f8f49bf-1971-449e-972e-b516418ea78e)

Company: https://www.keypedia.com/companies/manukamed-limited-partnership/ace7aa59-03e9-4e7a-8e09-addddf94f345

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd