FDA 483 - Berkshire Sterile Manufacturing, LLC - October 27, 2020

Berkshire Sterile Manufacturing, Inc. in Lee, MA, was inspected and cited for significant deficiencies in its quality control unit, particularly regarding deviation reporting and OOS investigations. The inspection also revealed issues with equipment cleaning procedures, microbiological contamination prevention, yield determination, and the validation of electronic records used for drug product specifications. These findings indicate a need for comprehensive improvements in the firm's quality management system.