# FDA 483 - SMITHS MEDICAL ASD, INC. - April 11, 2018

Source: https://www.keypedia.com/records/483/smiths-medical-asd-inc/dcaa64a6-9c1f-4b5f-bf75-f95666878031

> FDA 483 for SMITHS MEDICAL ASD, INC. on April 11, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SMITHS MEDICAL ASD, INC.
- Inspection Date: 2018-04-11
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of SMITHS MEDICAL ASD, INC. in Oakdale, MN, revealed a lack of an established quality plan and inadequate control over contract suppliers. Specifically, the firm failed to ensure that critical components for their Medfusion infusion pumps met specifications, leading to out-of-specification parts contributing to field failures. This indicates significant deficiencies in their quality management system.

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- [483 - 2023-06-09](https://www.keypedia.com/records/483/smiths-medical-asd-inc/fcc7c9db-a55d-42fe-a576-cea4c106d62a)

## Related Officers

- [Ralph W. Jerndal](https://www.keypedia.com/people/ralph-w-jerndal/f27d4e95-6601-492c-95e4-7638a6f48cc6)

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