# FDA 483 - Dongguan Kepler Special Cabling Company Limited - April 19, 2019

Source: https://www.keypedia.com/records/483/dongguan-kepler-special-cabling-company-limited/0d397cbe-447b-439f-9d6d-05ae5fd0e94c

> FDA 483 for Dongguan Kepler Special Cabling Company Limited on April 19, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dongguan Kepler Special Cabling Company Limited
- Inspection Date: 2019-04-19
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Dongguan Kepler Special Cabling Company Limited, a medical device manufacturer in Dongguan, China, revealed seven observations related to its quality system for contract manufactured Disposable ECG Cables. Deficiencies included inadequate process validation, uncontrolled production processes, and a lack of established procedures for finished device and in-process acceptance. The firm also failed to properly identify product acceptance status, adequately document acceptance activities, and ensure executive management review of the quality system.

## Related Officers

- [Felix J. Marrero](https://www.keypedia.com/people/felix-j-marrero/fe3bf64e-987b-40d9-8a17-754d58e13433)

Company: https://www.keypedia.com/companies/dongguan-kepler-special-cabling-company-limited/510fea0c-8dad-4817-863d-bb4b3fb0b79f

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