483
Dymax CorpDymax Corp – FDA 483, Jul 30, 2021
Record Details
An FDA inspection of Dymax Corp, a medical device manufacturer in Zelienople, PA, identified a significant issue with the control of non-conforming products. Specifically, the firm failed to adequately control Breast Biopsy System medical devices containing incorrectly wired cooling fans, resulting in the release and distribution of faulty units. This indicates a lapse in quality system controls for product specifications and release.
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ID · 9ad5066e-abe7-462f-8bff-ffa10aaeaed4
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