# FDA 483 - Medicore Co., Ltd. - November 09, 2023

Source: https://www.globalkeysolutions.net/records/483/medicore-co-ltd/b70c25ef-6eb6-4bc2-9ebb-3890474db9e6

> FDA 483 for Medicore Co., Ltd. on November 09, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Medicore Co., Ltd.
- Inspection Date: 2023-11-09
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Medicore Co., Ltd., a Class II device manufacturer in Seongnam, Gyeonggi, Korea, was cited with five observations during an FDA inspection from November 6-9, 2023. The inspection revealed significant deficiencies in quality system procedures, including inadequate complaint handling, non-conformance control, acceptance activities, device history records, and employee training. These issues indicate a systemic lack of robust quality management for their Max Pulse device.

## Related Officers

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Company: https://www.globalkeysolutions.net/companies/medicore-co-ltd/00ebb45b-0f71-4cd5-8215-bdf3dbdfbfa8

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