483
DiaPharma Group IncDiaPharma Group Inc – FDA 483, Apr 29, 2022
Record Details
DiaPharma Group Inc. in West Chester, OH, was inspected by the FDA from April 26-29, 2022. The inspection revealed a significant issue with the firm's design change procedures, specifically the lack of validation for design changes. This deficiency led to a packaging design change for a Factor X Kit being implemented and shipped without proper validation, despite being initiated due to customer complaints about broken vials.
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ID · f39982cd-9155-433c-b756-f215adf693ec
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