# FDA 483 - BM Korea Co. Ltd. - February 27, 2020

Source: https://www.globalkeysolutions.net/records/483/bm-korea-co-ltd/b41c0434-4d51-4f36-8152-82af82532019

> FDA 483 for BM Korea Co. Ltd. on February 27, 2020. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: BM Korea Co. Ltd.
- Inspection Date: 2020-02-27
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: BM KOREA CO., LTD., a medical device manufacturer in Gunpo, Gyeonggi, Korea, received a Form FDA 483 with seven observations during an inspection. The firm demonstrated significant deficiencies across its quality system, including inadequate procedures for document control, complaint handling, nonconforming product, environmental conditions, design review, and device history records. Additionally, the company lacked an established quality policy from executive management.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/bm-korea-co-ltd/9eaac461-ec3b-444c-9b9c-d7bea5fc2d7b

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