FDA EIR - Avantor Inc. - August 12, 2019

An FDA surveillance inspection of Avantor Inc.'s Phillipsburg, NJ facility, a manufacturer, repacker, and tester of human Active Pharmaceutical Ingredients (APIs), was conducted from August 6-12, 2019. The inspection was guided by regulatory frameworks including CPGM 7356.002, CPGM 7356.002F, and ICH Q7 Good Manufacturing Practices for APIs, which ensure product quality and safety.

The inspection identified two primary concerns. Firstly, the firm was not performing annual product reviews for APIs manufactured at the facility, failing to follow their established procedure (SOP PRO-00049). This omission hinders a comprehensive assessment of product quality trends. Secondly, the warehouse, which stores raw materials, intermediates, and finished APIs, lacked consistent temperature and humidity monitoring. This is critical as some stored products, like Galactose and Sodium Phosphate, have specified "room temperature" stability conditions, and the absence of monitoring, along with no prior temperature mapping study, could compromise product integrity.

While no FDA-483 was issued, management acknowledged these observations during the close-out meeting, indicating an understanding of the need to address these issues. Minor facility maintenance concerns, such as broken floors and an open roof, were corrected during the inspection. The expectation is that Avantor Inc. will implement corrective actions to ensure compliance with quality system requirements and proper environmental controls for API storage.