# FDA 483 - GOOD DOCTORS CO., LTD. - May 23, 2019

Source: https://www.globalkeysolutions.net/records/483/good-doctors-co-ltd/61fcb166-3a4a-4591-9771-dbe2fff8e695

> FDA 483 for GOOD DOCTORS CO., LTD. on May 23, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: GOOD DOCTORS CO., LTD.
- Inspection Date: 2019-05-23
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of GOOD DOCTORS CO., LTD. in Incheon, Korea, revealed significant deficiencies in their quality system for manufacturing the Dr's Light G dental composite curing light. The firm lacked adequate procedures for design change, validation, and verification, as well as for handling complaints and Medical Device Reporting. Additionally, equipment calibration procedures were not properly followed.

## Related Officers

- [Regulatory Review Officer](https://www.globalkeysolutions.net/people/quynh-strandberg/9b582ae6-85f9-4163-8ce6-b179c5fd340e)

Company: https://www.globalkeysolutions.net/companies/good-doctors-co-ltd/281f9b46-656c-48a8-9507-3586cd609cdc

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