FDA EIR - JOHNSON AND JOHNSON CONSUMER INC MCNEIL CONSUMER HEALTHCARE DIV - October 07, 2022

An FDA Postmarketing Adverse Drug Experience (PADE) surveillance inspection of Johnson and Johnson Consumer Inc, Div Of Mcneil,Inc. was conducted from October 4-7, 2022, in Fort Washington, PA. The inspection, guided by Compliance Program Guide 7353.001, focused on the company's pharmacovigilance processes for both approved (NDA/ANDA) and OTC Monograph drug products. A key finding was the successful remediation of issues from a 2014 inspection regarding untimely submission of expedited PADE reports. During this current inspection, no formal FDA Form 483 (Inspectional Observations) was issued. However, the inspection identified 457 late expedited adverse event cases, which the company attributed primarily to a technical mapping error in their global safety database and an increased reporting volume following a product recall. While no formal regulatory actions were mandated, discussions with management focused on the importance of ensuring adequate vendor oversight in reporting late cases, maintaining business partner compliance with adverse event submissions, and enhancing monitoring of all adverse event surveillance and receipt channels to ensure timely reporting. The company acknowledged these points for continuous improvement.