# FDA 483 - Dragon Heart Medical Inc. - July 02, 2021

Source: https://www.globalkeysolutions.net/records/483/dragon-heart-medical-inc/05cab6bd-d8e6-44d4-be44-23520e8cce48

> FDA 483 for Dragon Heart Medical Inc. on July 02, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dragon Heart Medical Inc.
- Inspection Date: 2021-07-02
- Product Type: device
- Office Name: Chicago District Office
- Summary: Dragon Heart Medical Inc., a medical device specification developer and initial importer in Elmhurst, IL, was cited for four significant quality system deficiencies during an FDA inspection. These issues include inadequate design history files, poorly maintained device master records, insufficient supplier controls, and poorly documented corrective and preventive actions, with two of the observations being repeat findings. The findings indicate systemic problems in maintaining compliant quality system records and procedures.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/amanda-dinaro/6df79979-ad5c-46f5-8917-197f8a0870e0)

Company: https://www.globalkeysolutions.net/companies/dragon-heart-medical-inc/d1ab22fc-e6d1-4825-af2f-d526a2840e75

Office: https://www.globalkeysolutions.net/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669