FDA 483 - Berkshire Sterile Manufacturing, LLC - October 15, 2021

An FDA inspection of Berkshire Sterile Manufacturing, Inc. in Lee, MA, revealed six observations related to sterile drug product manufacturing. Deficiencies included inadequate sterilization and testing of drug product containers, breaches in aseptic technique, failure to validate supplier test results for components, and significant issues with cleaning and disinfection of aseptic processing areas. Additionally, the firm failed to complete equipment performance qualification and exhibited scientifically unsound laboratory control procedures for product testing.