# FDA 483 - GBS Commonwealth Co., Ltd. - February 20, 2020

Source: https://www.globalkeysolutions.net/records/483/gbs-commonwealth-co-ltd/5f287841-f7e7-470a-9064-701c3a62cafd

> FDA 483 for GBS Commonwealth Co., Ltd. on February 20, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: GBS Commonwealth Co., Ltd.
- Inspection Date: 2020-02-20
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of GBS Commonwealth Co., Ltd., a medical device manufacturer in Geumcheon, Seoul, revealed significant deficiencies across its quality system. The firm failed to adequately manage design controls, validate software, evaluate suppliers, control documents, and maintain personnel training records. These issues indicate a systemic lack of adherence to regulatory requirements for medical device manufacturing.

## Related Officers

- [Jude C. Dike](https://www.globalkeysolutions.net/people/jude-c-dike/ea760122-1121-420a-9875-c49de6f3bb0e)

Company: https://www.globalkeysolutions.net/companies/gbs-commonwealth-co-ltd/a0853ef7-4f6c-42fa-8634-fced1c4e8060

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