FDA 483 - Berkshire Sterile Manufacturing, LLC - October 21, 2024

An FDA inspection of Berkshire Sterile Manufacturing in Lee, MA, revealed significant deficiencies in their sterile drug product manufacturing operations. Observations included inadequate aseptic processing procedures, insufficient environmental monitoring, and a lack of proper investigation into quality events. These findings indicate a high risk of microbial contamination and compromised product quality for their sterile injectable drug products.