483
E-Beam Services IncE-Beam Services Inc – FDA 483, Sep 26, 2023
Record Details
An FDA inspection of E-Beam Services Inc in Lebanon, OH, from September 20-26, 2023, revealed a significant issue with process validation. The firm failed to adequately validate processes, specifically lacking documentation for performance qualification (PQ) activities for medical device products undergoing sterilization, as required by their own established procedures.
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ID · 360515c5-3c0f-4ce6-96c4-5fd5a1d13a93
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