# FDA 483 - Dragon Heart Medical Devices Co., Ltd. - September 13, 2018

Source: https://www.keypedia.com/records/483/dragon-heart-medical-devices-co-ltd/b3389d54-8989-47fb-8eea-0d62f2bd3ec9

> FDA 483 for Dragon Heart Medical Devices Co., Ltd. on September 13, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dragon Heart Medical Devices Co., Ltd.
- Inspection Date: 2018-09-13
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Dragon Heart Medical Devices Co., Ltd. in Kaiping, China, a medical device manufacturer, was cited with two observations during an FDA inspection. The firm failed to adequately validate its EO sterilization process and maintain associated production records. Additionally, the company did not establish adequate procedures for handling customer complaints, leading to several complaints not being entered into their system for investigation.

## Related Officers

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

Company: https://www.keypedia.com/companies/dragon-heart-medical-devices-co-ltd/b45e173a-530f-4ddf-bbd1-db2481e739d5

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