FDA 483 - Berkshire Sterile Manufacturing, LLC - August 25, 2023

Berkshire Sterile Manufacturing, Inc. in Lee, MA, was inspected regarding its sterile drug manufacturing operations. The inspection revealed a critical lapse in procedures designed to prevent microbiological contamination, specifically an operator blocking laminar airflow during aseptic vial filling and stoppering of PEDMARK Sodium Thiosulphate Injection. This indicates a significant concern for maintaining sterility during production.