FDA 483 - Berkshire Sterile Manufacturing, LLC - January 20, 2023

Between January 16 and January 20, 2023, the Food and Drug Administration (FDA) conducted an inspection of Berkshire Sterile Manufacturing (BSM) in Lee, Massachusetts. The inspection identified several critical deficiencies in the facility"s manufacturing and quality control processes. Key violations included inadequate handling of deviations, where the company failed to limit or properly justify extensions for internal investigations. BSM also demonstrated poor raw material oversight, specifically using unqualified suppliers for glass vials and failing to adhere to quality agreements regarding material procurement. Furthermore, the FDA noted a lack of established and validated cleaning procedures for major equipment, missing instructions for contamination control during drug filling, and a failure to validate shipping conditions for products stored at sub-zero temperatures. These observations were issued under the authority of Section 704 of the Federal Food, Drug, and Cosmetic Act. Although these findings do not represent a final compliance determination, BSM is required to respond by either discussing corrective actions with the FDA representative or submitting a formal written response. The company must demonstrate how it will rectify these objectionable practices to ensure the safety and quality of its manufactured products.