# FDA 483 - Harmar Mobility, LLC. - July 15, 2022

Source: https://www.keypedia.com/records/483/harmar-mobility-llc/762e2e03-fb2e-49c9-9d5d-40ca66c5bbbb

> FDA 483 for Harmar Mobility, LLC. on July 15, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Harmar Mobility, LLC.
- Inspection Date: 2022-07-15
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: An FDA inspection of Harmar Mobility, LLC. in Lake Winnebago, MO, a manufacturer of medical devices, revealed significant deficiencies in their quality system. The firm failed to adequately establish procedures for design validation, corrective and preventive actions, training, equipment calibration, equipment maintenance, and complaint handling. These findings indicate a systemic lack of adherence to regulatory requirements for medical device manufacturing.

## Related Officers

- [Eric C. Fox](https://www.keypedia.com/people/eric-c-fox/218af117-1551-476f-80ba-172e2cd6baee)
- [Alex J. Wild](https://www.keypedia.com/people/alex-j-wild/bb1b66b3-19b9-480e-af0b-f06f8de0d930)

Company: https://www.keypedia.com/companies/harmar-mobility-llc/dd89afdc-ac56-4b54-be1b-969f199bf948

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8