FDA 483 - Berkshire Sterile Manufacturing, LLC - June 12, 2024

Berkshire Sterile Manufacturing, LLC, a sterile drug manufacturer in Lee, MA, was cited with four observations during an FDA inspection. The observations primarily concern inadequate equipment calibration, insufficient procedures to prevent microbiological contamination of sterile products, failure to thoroughly investigate discrepancies and batch failures, and improper storage and segregation of raw materials. These issues indicate significant deficiencies in quality control and manufacturing practices for sterile drug products.