FDA EIR - Tergus Pharma LLC - September 27, 2019

An FDA inspection was conducted at Tergus Pharma LLC in Durham, NC, from September 23 to September 27, 2019. This announced inspection, assigned by the Center for Drug Evaluation and Research (CDER) under Compliance Program Guidance Manual CPGM 7348.004, focused on verifying analytical data and methods for an Abbreviated New Drug Application (ANDA) submission. The inspection also aimed to confirm corrective actions taken since a previous FDA inspection in October 2016. During the 2016 inspection, Tergus Pharma received an FDA Form 483 and an "Official Action Indicated" classification for several issues, including inadequate storage of reserve samples, insufficient drug accountability records, issues with calibration standards, lack of quality control samples for accuracy/precision, and use of expired products. For the current inspection, auditors reviewed various aspects of the analytical laboratory's operations, including method validation, sample analysis, data integrity, and documentation for a specific bioequivalence study. Notably, the inspection team did not observe any objectionable conditions and, consequently, did not issue an FDA Form 483. This indicates successful remediation of previous issues, particularly the implementation of a secure area for retention samples, which was a specific voluntary correction noted. No further regulatory actions were required as a direct result of this inspection.