483
Biedermann Motech, Inc.Biedermann Motech, Inc. – FDA 483, Oct 15, 2019
Record Details
Biedermann Motech, Inc. in Miami, FL, a specification developer and contract manufacturer, received a Form 483 for significant quality system deficiencies. The inspection revealed multiple failures in validation processes, including cleaning, manufacturing, design, and software for medical device instruments. Additionally, issues were identified with incoming product acceptance and supplier monitoring documentation.
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ID · 1bc5f1e6-d9cd-4f3d-b66d-865e31acbd6d
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