FDA 483 - PharmaEssentia Corporation, Taichung Plant - April 18, 2023

An FDA inspection conducted at PharmaEssentia Corporation ’s Taichung Plant, a drug substance manufacturer, from April 10-14 and 17-18, 2023, resulted in the issuance of a Form FDA 483 listing key observations. The findings highlight areas requiring immediate attention to ensure compliance with good manufacturing practices.

A significant concern involved the company's handling of at least 48 complaints regarding a lack of therapeutic efficacy, received between April 2022 and February 2023. Investigations into these critical complaints were found to be incomplete, lacking essential reviews of batch manufacturing records, analytical testing data, and evaluations of retention samples. Moreover, none of these investigations had been formally closed.

Additionally, the inspection identified deficiencies in the firm's bacterial endotoxin testing method, specifically the Kinetic Turbidimetric LAL Assay. The method validation failed to assess the suitability of containers used for sample collection and storage. Furthermore, the established procedure did not require the use of a calibrated timer, and an uncalibrated device was observed in use during testing. These observations underscore the need for PharmaEssentia Corporation to implement prompt and thorough corrective actions to uphold product quality and regulatory standards.