FDA EIR - Taro Pharmaceuticals U.S.A., Inc. - August 27, 2018

An FDA surveillance inspection of Taro Pharmaceuticals U.S.A., Inc., based in Hawthorne, NY, took place on August 27, 2018. The inspection was a Postmarketing Adverse Drug Experience (PADE)-initiated review, conducted under Compliance Program 7353.001, which specifically governs the reporting of adverse drug events. This regulatory framework ensures that pharmaceutical companies effectively monitor and report potential side effects and safety issues associated with their marketed products. The inspection's scope centered on Taro's systems for the surveillance, receipt, evaluation, and submission of adverse drug event data. The company, which develops and markets brand and generic prescription drugs, as well as over-the-counter products manufactured in Israel and Canada, outsources portions of its PADE responsibilities, including intake of ADEs and complaints, to a third-party contractor. During the comprehensive review of various records, including written procedures, contractor agreements, adverse drug experience case files, complaint logs, and annual reports, the FDA investigator identified no discrepancies. As a result, an FDA Form 483, Inspectional Observations, was not issued to Taro Pharmaceuticals U.S.A., Inc. This favorable outcome indicates that the firm was found to be operating in compliance with the established regulatory requirements for postmarketing adverse drug experience reporting, and no specific violations or required actions were cited from this inspection.