FDA EIR - Genus Lifesciences Inc. - November 28, 2018

An FDA inspection of Genus Lifesciences Inc., located in Allentown, PA, was conducted from November 27-28, 2018. This routine surveillance inspection focused on the company's compliance with Postmarketing Adverse Drug Experience (PADE) reporting regulations, as outlined in Compliance Program 7353.001. The inspection covered safety reporting and submissions from the previous inspection up to the current date.

While the inspection concluded without the issuance of an official Form FDA-483, it identified one significant discussion item: a lack of adequate oversight by Genus Lifesciences Inc. over its contracted pharmacovigilance firm. This deficiency resulted in five late 15-day alerts for serious, unexpected adverse drug events, specifically those identified through literature reviews. The contractor had failed to conduct required literature searches for approximately two years, from June 2016 to July 2018. Genus Lifesciences became aware of this lapse only after the contractor reported their findings in July 2018, leading to delays in processing these alerts.

In response, Genus Lifesciences Inc. was advised to improve its oversight of contracted organizations. The company committed to implementing a monthly reconciliation process for adverse drug experiences and literature searches to prevent future omissions and agreed to document its corrective and preventive actions (CAPA) in writing. Notably, previous discussion points from an August 2016 inspection regarding staff training on adverse event handling and annual report submissions were found to have been successfully addressed.