FDA 483 - Berkshire Sterile Manufacturing, LLC - March 05, 2026

Sharp Sterile Manufacturing, LLC in Lee, MA, was inspected and received a Form 483 with six observations related to significant quality control and manufacturing deficiencies. The firm failed to adequately investigate quality failures, maintain equipment to prevent contamination, control pest entry, and follow procedures for sterile product manufacturing, quality unit responsibilities, and aseptic cleaning. These issues indicate a serious lack of control over sterile drug product quality and integrity.