FDA EIR - Berkshire Sterile Manufacturing, LLC - October 15, 2021

An FDA inspection of Berkshire Sterile Manufacturing, Inc., a sterile drug contract manufacturer in Lee, MA, was conducted from October 4 to October 15, 2021. This pre-announced "for cause" inspection, following CPGM 7356.002A (Sterile Drug Process Inspections), covered Quality, Production, Materials, Facilities and Equipment, and Laboratory Control Systems. The inspection resulted in a six-item Form FDA 483, identifying significant concerns. Violations included inadequate cleaning and sterilization of drug product containers, insufficient procedures to prevent microbiological contamination in sterile drugs, and deficiencies in aseptic processing area cleaning and disinfection. The firm also accepted supplier certificates for container/closure testing without validating reliability and used equipment not appropriately designed for its intended use. Furthermore, laboratory controls lacked scientifically sound test procedures to ensure drug product quality. The report also noted issues with investigation depth for product deviations, particularly concerning particulates in sterile products, and an obscured exit vent impacting airflow. This inspection followed a previous October 2020 inspection that led to an Official Action Indicated (OAI) letter. While some prior corrections were made, the FDA indicated that the adequacy of the firm’s investigation approach requires further assessment. The company's President & CEO committed to submitting a written response to the FDA's observations within 15 business days.