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

Berkshire Sterile Manufacturing in Lee, MA, was inspected from October 14-21, 2024, and received eight observations primarily related to significant deficiencies in aseptic processing, environmental monitoring, and quality control. The findings indicate a high risk of microbial contamination and product quality issues due to inadequate procedures, training, and facility maintenance.