Janssen Sciences Ireland UCApril 30, 2021

FDA 483 - Janssen Sciences Ireland UC - April 30, 2021

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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.

Company: Janssen Sciences Ireland UC
Inspection Date: April 30, 2021
Product Type: Drugs
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
People: Sarah A. Johnson
Madushini N. Dharmasena

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ID · c0958b0a-4c15-4f4b-bd73-dd9837ad10c4