E-Beam Services IncSeptember 26, 2023

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

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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.

Company: E-Beam Services Inc
Inspection Date: September 26, 2023
Product Type: Device
Office: Cincinnati District Office
Person: Javonica F. Penn (investigator)

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ID · 360515c5-3c0f-4ce6-96c4-5fd5a1d13a93