483
Cardionics, IncFDA 483 - Cardionics, Inc - August 30, 2023
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Cardionics, Inc., a medical device manufacturer in Webster, TX, was cited with two observations during an FDA inspection. The firm failed to adequately document rework activities, specifically lacking determination of adverse effects on products and retention of failed test results. Additionally, the company's training procedures and records for personnel were found to be inadequately established and maintained.
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ID · ee131ca3-3691-4ecd-8033-4cd04bb50011