483
E-Beam Services IncFDA 483 - E-Beam Services Inc - September 26, 2023
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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