483
Janssen Sciences Ireland UCJanssen Sciences Ireland UC – FDA 483, Apr 30, 2021
Record Details
An FDA inspection of Janssen Sciences Ireland UC in Ringaskiddy, Co. Cork, Ireland, from April 26-30, 2021, identified a significant quality control deficiency. The firm failed to adequately investigate invalid assays, even when rates exceeded internal SOP thresholds. This indicates a lapse in their laboratory quality management and investigation processes.
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ID · c0958b0a-4c15-4f4b-bd73-dd9837ad10c4
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