New York Firm Cited for Pharmacovigilance Violations

Jerome Stevens Pharmaceuticals was hit with a Form 483 by the FDA for failing to comply with postmarketing requirements.

An inspection of the firm’s Bohemia, New York facility revealed that the company — which used a contract pharmacovigilance firm — sent incomplete postmarketing adverse drug experience (PADE) reports to the agency.

Reports submitted in 2017 and 2018 lacked an analysis of 15-day alert reports or actions taken in response to the adverse events, the agency investigators said.

In addition, the firm failed to submit annual PADE reports for several drugs approved in 2015, including generic cephalexin and aspirin-methocarbamol.