FDA EIR - Teligent Pharma, Inc. - January 22, 2016

An FDA inspection of Teligent, Inc., located in Buena, NJ, was conducted from January 12-22, 2016. The inspection operated under the New Jersey District FY2016 Drug Workplan, encompassing Drug Good Manufacturing Practice (GMP), Pre-approval, and Postmarketing Adverse Drug Experience (PADE) regulatory frameworks. While the inspection found no deficiencies in quality, production, laboratory control systems, pre-approval applications, or adverse drug event reporting—and no FDA-483 observations were issued—a key issue from a prior inspection resurfaced.

Teligent had previously committed in December 2013 to cease manufacturing unapproved prescription drugs by December 2014. However, in May 2015, the company manufactured and shipped lots of these unapproved products following a customer request, under the belief that they were part of an Investigational New Drug (IND) review. During this inspection, Teligent provided a written commitment to permanently discontinue manufacturing these specific unapproved products.

Additionally, in response to discussions regarding older pending applications, Teligent committed in writing to perform pre-validation studies before commercializing any products from Abbreviated New Drug Applications (ANDAs) that were submitted more than five years prior to approval. Management was also advised to keep the District informed and updated on any future facility expansion plans.