# FDA 483 - Smiths Medical ASD, Inc. - March 03, 2023

Source: https://www.globalkeysolutions.net/records/483/smiths-medical-asd-inc/b61bd758-f031-4046-b0c7-2f8847bf0a5a

> FDA 483 for Smiths Medical ASD, Inc. on March 03, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Smiths Medical ASD, Inc.
- Inspection Date: 2023-03-03
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: Smiths Medical ASD Inc., a medical device manufacturer in Minneapolis, MN, was cited with three observations during an FDA inspection. The firm failed to adequately implement procedures for Medical Device Reporting (MDR), control of nonconforming products, and Corrective and Preventive Actions (CAPA). These deficiencies indicate significant issues with the firm's quality system.

## Related Documents

- [483 - 2021-04-30](https://www.globalkeysolutions.net/records/483/smiths-medical-asd-inc/650179b5-6565-47c9-b068-4ccc6d9501ad)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/tyler-r-courtney/08ea96c4-cd5a-4793-b7e4-fb2b9ee2b9ef)
- [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