# FDA 483 - Sooil Development Co., Ltd. - January 23, 2020

Source: https://www.keypedia.com/records/483/sooil-development-co-ltd/53948ae5-cc26-4d71-ad4d-a5780da5abd1

> FDA 483 for Sooil Development Co., Ltd. on January 23, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sooil Development Co., Ltd.
- Inspection Date: 2020-01-23
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Soci. Development Co., Ltd. in Gyeonggi-do, Gyeonggi, Korea, identified eight observations related to inadequate procedures across various quality system elements. The firm failed to establish adequate procedures for management review, quality audits, corrective and preventive actions, MDRs, calibration, environmental controls, supplier management, and training. These findings indicate significant deficiencies in the firm's quality management system.

## Related Documents

- [WARNING_LETTER - 2020-01-23](https://www.keypedia.com/records/warning_letter/sooil-development-co-ltd/c53e2407-e3de-4044-a1a2-09e2bca43dc2)

## Related Officers

- [investigator](https://www.keypedia.com/people/john-a-sciacchitano/9f8f49bf-1971-449e-972e-b516418ea78e)

Company: https://www.keypedia.com/companies/sooil-development-co-ltd/143e4065-e074-4301-b860-2b20304c5678

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