# FDA 483 - MODERN MEDICAL EQUIPMENT MANUFACTURING LTD. - July 12, 2018

Source: https://www.globalkeysolutions.net/records/483/modern-medical-equipment-manufacturing-ltd/c9e0df23-6892-4372-adc1-3b3c24f887b9

> FDA 483 for MODERN MEDICAL EQUIPMENT MANUFACTURING LTD. on July 12, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: MODERN MEDICAL EQUIPMENT MANUFACTURING LTD.
- Inspection Date: 2018-07-12
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Modern Medical Equipment Manufacturing LTD in Hengli, China, was inspected by the FDA from July 9-12, 2018. The inspection revealed significant deficiencies in complaint handling, CAPA management, stability studies, and various aspects of design control for their disposable electrode products. The findings indicate a need for comprehensive improvements in their quality system.

## Related Documents

- [483 - 2018-07-09](https://www.globalkeysolutions.net/records/483/modern-medical-equipment-manufacturing-ltd/2ff24108-4aef-48bd-b172-42cf414a059c)

## Related Officers

- [Ashley A. Mutawakkil](https://www.globalkeysolutions.net/people/ashley-a-mutawakkil/512be391-fd96-451c-9569-98e43cfba9db)

Company: https://www.globalkeysolutions.net/companies/modern-medical-equipment-manufacturing-ltd/01709317-4aa1-4327-99d1-af7b4af8b387

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