FDA EIR - Avantor Inc. - August 03, 2018

An FDA surveillance inspection of Avantor Inc.'s Phillipsburg, NJ facility was conducted from July 31 to August 3, 2018. The inspection focused on the company's manufacturing, repackaging, and testing of human active pharmaceutical ingredients (APIs), ensuring compliance with current Good Manufacturing Practices (cGMP) as outlined in CPGM 7356.002, CPGM 7356.002F, and ICH Q7 guidelines for APIs. While no formal Inspectional Observations (FDA 483) were issued, investigators verbally discussed two significant areas for improvement with management. First, the facility lacked consistent monitoring of temperature and humidity in its manufacturing and warehouse sections, particularly concerning raw materials and APIs requiring specific storage conditions. A comprehensive warehouse temperature and humidity mapping study had also not been performed. Second, Avantor Inc. had not conducted annual product quality reviews for its API drug products in 2015 or 2017 and did not have an established procedure for these critical evaluations of batch records. To address these findings, Avantor Inc. is required to implement robust environmental monitoring controls, including a temperature and humidity mapping study, and establish a formal procedure for conducting regular annual product quality reviews to ensure sustained product quality and regulatory adherence.