FDA 483 - Berkshire Sterile Manufacturing, LLC - May 23, 2022

An FDA inspection of Berkshire Sterile Manufacturing, LLC in Lee, MA, revealed significant deficiencies in their manufacturing processes and quality control. The firm lacked written procedures and supporting data for critical changes to manufacturing equipment and an expired terminal sterilization validation. Additionally, the company failed to conduct annual visual examinations of reserve drug product samples for signs of deterioration.