# FDA 483 - Smiths Medical ASD, Inc. - April 30, 2021

Source: https://www.globalkeysolutions.net/records/483/smiths-medical-asd-inc/650179b5-6565-47c9-b068-4ccc6d9501ad

> FDA 483 for Smiths Medical ASD, Inc. on April 30, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Smiths Medical ASD, Inc.
- Inspection Date: 2021-04-30
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of Smiths Medical ASD Inc. in Minneapolis, MN, revealed significant deficiencies in the firm's quality system, particularly concerning design validation, corrective and preventive actions, and complaint handling for their Medfusion infusion pumps. The inspection found unvalidated software combinations, inadequate CAPA implementation and verification, and failures to properly investigate and report adverse events, some of which were associated with patient deaths and serious injuries. These issues indicate a systemic breakdown in ensuring device safety and effectiveness.

## Related Documents

- [483 - 2023-03-03](https://www.globalkeysolutions.net/records/483/smiths-medical-asd-inc/b61bd758-f031-4046-b0c7-2f8847bf0a5a)

## Related Officers

- [Investigator ](https://www.globalkeysolutions.net/people/christina-l-bigham/f3da8e26-4a8c-43a8-8070-349fe4500289)

Company: https://www.globalkeysolutions.net/companies/smiths-medical-asd-inc/e574d600-79d9-4efb-b599-8520f202268a

Office: https://www.globalkeysolutions.net/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d