Johnson & Johnson Consumer, IncMarch 24, 2021

FDA 483 - Johnson & Johnson Consumer, Inc - March 24, 2021

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Johnson & Johnson Consumer, Inc. in Lancaster, PA, a drug manufacturer, was cited for failing to thoroughly review batch failures and their components. Specifically, the firm's investigation reports for Imodium Multi-Symptom Relief tablet compression and yield deviations were inadequate in assessing root causes and implementing effective corrective and preventative actions. This indicates a significant lapse in quality control and investigation processes.

Company: Johnson & Johnson Consumer, Inc
Inspection Date: March 24, 2021
Product Type: Drugs
Office: Philadelphia District Office
People: Michele Gottshall
Anastasia M. Shields (Consumer Safety Officer )

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ID · 451e3a89-7423-4e12-b139-81b82b0bf727