# FDA 483 - Williams Sound LLC - February 28, 2019

Source: https://www.keypedia.com/records/483/williams-sound-llc/60446519-dde1-47c1-ae15-498077bd5512

> FDA 483 for Williams Sound LLC on February 28, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Williams Sound LLC
- Inspection Date: 2019-02-28
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: Williams Sound LLC, a medical device manufacturer in Eden Prairie, MN, was inspected by the FDA. The inspection revealed a significant deficiency where the firm failed to establish documented procedures for design control, specifically addressing the requirements of 21 CFR 820.30. This indicates a fundamental gap in their quality system for medical device design.

## Related Officers

- [investigator](https://www.keypedia.com/people/yehualashet-a-gessesse/cb732900-358c-4982-a912-e98fa45142fe)

Company: https://www.keypedia.com/companies/williams-sound-llc/06b02329-447f-4dd9-b820-f93fc7727690

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