# FDA 483 - SMC - December 11, 2025

Source: https://www.keypedia.com/records/483/smc/640a60ca-ee3f-432f-a21b-08347e26430c

> FDA 483 for SMC on December 11, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SMC
- Inspection Date: 2025-12-11
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Operations
- Summary: SMC, a medical device manufacturer in Gimpo-si, Gyeonggi-do, Korea, received a Form FDA 483 with three observations. The inspection revealed significant deficiencies in the firm's quality system, including failures in corrective and preventive action procedures, lack of written Medical Device Reporting procedures, and inadequate supplier change notification agreements. These issues indicate a need for comprehensive improvements in the firm's quality management.

## Related Officers

- [Sunita Pandey](https://www.keypedia.com/people/sunita-pandey/008e5bb8-0eb3-45d8-8524-734ac0454250)

Company: https://www.keypedia.com/companies/smc/b3d1d209-b929-4dbc-bbd5-d4eaabcaf24d

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-operations/27658190-735a-443e-9087-3534cfe74fd4