FDA EIR - Janssen Pharmaceuticals, dba Actelion Pharmaceutical - February 28, 2019

An FDA inspection of Janssen Pharmaceuticals, dba Actelion Pharmaceutical, in South San Francisco, California, occurred from February 25 to February 28, 2019. This routine postmarket adverse drug experience (PADE) inspection, conducted under Compliance Program 7353.001, thoroughly reviewed the company's drug safety management and reporting systems for products such as Tracleer, Zavesca, and Opsumit. The main observation was the delayed submission of numerous adverse event (AE) reports, which were reported beyond the required 15-day timeframe. This finding echoed a similar issue from a previous inspection in September 2016, which led to an FDA 483 observation for untimely report submissions. During the current inspection, the FDA acknowledged that Actelion's Drug Safety Group is actively engaged in corrective and preventive actions (CAPA) to mitigate late reporting. At the close-out meeting, the investigator verbally urged management to continue these efforts to ensure timely report submissions. No formal FDA 483 was issued during this inspection, reflecting the firm's ongoing commitment to addressing the identified reporting deficiencies.