# FDA 483 - Kenex (Electro-Medical) Ltd. - March 14, 2024

Source: https://www.globalkeysolutions.net/records/483/kenex-electro-medical-ltd/8d101d58-9a9f-41af-9f34-083738a7e2ae

> FDA 483 for Kenex (Electro-Medical) Ltd. on March 14, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kenex (Electro-Medical) Ltd.
- Inspection Date: 2024-03-14
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Kenex (Electro-Medical) Ltd., a medical device manufacturer in Harlow, United Kingdom, was inspected by the FDA from March 11-14, 2024. The inspection revealed significant deficiencies across multiple quality system areas, primarily concerning the lack of established procedures for design control, complaint handling, process control, finished device acceptance, labeling, and Medical Device Reporting (MDR) for their Mobile Detector Holder product. These findings indicate a broad failure to implement essential quality system requirements for medical device manufacturing.

## Related Officers

- [Thai T. Duong](https://www.globalkeysolutions.net/people/thai-t-duong/59737092-2f30-43a7-b23b-36fa7f212c4a)

Company: https://www.globalkeysolutions.net/companies/kenex-electro-medical-ltd/1b979611-c01d-4e9e-888f-790122d8b45f

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