# FDA 483 - Medtronic (Changzhou) Medical Devices Technology Co Ltd - August 20, 2015

Source: https://www.globalkeysolutions.net/records/483/medtronic-changzhou-medical-devices-technology-co-ltd/64e5cc3b-3079-4ce5-8477-f03e3cae3eef

> FDA 483 for Medtronic (Changzhou) Medical Devices Technology Co Ltd on August 20, 2015. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Medtronic (Changzhou) Medical Devices Technology Co Ltd
- Inspection Date: 2015-08-20
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Changzhou Kanghui Medical Innovation Co., Ltd. in Changzhou, China, was inspected by the FDA from August 17-20, 2015. The inspection revealed significant deficiencies in the firm's quality system, specifically regarding corrective and preventive action procedures and device history record management. These issues indicate a lack of adequate controls over product quality and record-keeping.

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## Related Officers

- [Janete F. Guardia](https://www.globalkeysolutions.net/people/janete-f-guardia/2405f83f-7ea9-4056-afbd-7d9c00a6e169)

Company: https://www.globalkeysolutions.net/companies/medtronic-changzhou-medical-devices-technology-co-ltd/1b44f0c6-cd3a-4380-850e-b1ffbc4d0c43

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