483
Williams Sound LLCFDA 483 - Williams Sound LLC - February 28, 2019
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Record Details
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.
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ID · 60446519-dde1-47c1-ae15-498077bd5512