483
Advanced Bionics, LLCAdvanced Bionics, LLC – FDA 483, Sep 28, 2018
Record Details
Advanced Bionics, LLC, a medical device manufacturer in Valencia, CA, received two observations during an FDA inspection. The firm was cited for inadequate documentation of design verification results, specifically lacking source data for mechanical impact performance. Additionally, the inspection revealed a failure to adequately control non-conforming products, leading to their re-entry into production after initial quarantine.
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ID · 51cb9635-2331-4dfa-96d5-8333a7cb3b68
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