FDA EIR - Avantor Performance Materials LLC - April 14, 2021

An FDA routine Current Good Manufacturing Practice (cGMP) surveillance inspection of Avantor Performance Materials LLC, a pharmaceutical excipient and active pharmaceutical ingredient (API) repackager in Paris, KY, was conducted from April 7-14, 2021. This inspection, performed under Compliance Program 7356.002, identified several significant deficiencies. The main violations, formally cited in an FDA-483 observation, included inadequate and inconsistently performed preventative maintenance for equipment. Specifically, cleaning systems did not consistently meet required operating parameters, and production scale weight checks were not performed as stipulated. Furthermore, the company was cited for insufficient record-keeping for maintenance activities, with missing documentation for cleaning equipment and inadequate detail regarding contracted HEPA filter replacements. A critical finding was the absence of a secondary review to ensure the accuracy and completeness of various maintenance logs, including those for HEPA filters, water systems, cleaning equipment, and scale checks. Beyond these formal observations, the inspectors noted additional concerns, such as incomplete investigations into customer complaints that did not fully assess supplier involvement, a production employee failing to comply with gowning procedures (beard not fully covered), and the lack of formal quality agreements with third-party suppliers and outsourced laboratory services. Company management acknowledged these findings and committed to submitting a written response detailing corrective and preventative actions within 15 business days.