# FDA 483 - SMITHS MEDICAL ASD, INC. - June 09, 2023

Source: https://www.keypedia.com/records/483/smiths-medical-asd-inc/fcc7c9db-a55d-42fe-a576-cea4c106d62a

> FDA 483 for SMITHS MEDICAL ASD, INC. on June 09, 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: 2023-06-09
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of Smiths Medical ASD, Inc. in Oakdale, MN, revealed significant deficiencies in process control procedures and the handling of nonconforming products. Operators were found to be deviating from established testing protocols, and the firm's investigation into nonconformances failed to adequately identify all potentially affected products, some of which were distributed. These issues indicate a breakdown in quality system adherence and oversight.

## Related Documents

- [483 - 2018-04-11](https://www.keypedia.com/records/483/smiths-medical-asd-inc/dcaa64a6-9c1f-4b5f-bf75-f95666878031)

## Related Officers

- [investigator](https://www.keypedia.com/people/tyler-r-courtney/08ea96c4-cd5a-4793-b7e4-fb2b9ee2b9ef)
- [Albert L. Nguyen](https://www.keypedia.com/people/albert-l-nguyen/496338d0-71c4-43da-92f0-09515559d9fc)

Company: https://www.keypedia.com/companies/smiths-medical-asd-inc/56c6b68b-9586-41b3-9286-7ffe19656e52

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