Berkshire Sterile Manufacturing, LLC – FDA 483, Jan 20, 2023

Berkshire Sterile Manufacturing (BSM) in Lee, MA, an excipient gel manufacturer, was cited for multiple deficiencies during an FDA inspection. Observations included inadequate written procedures for deviation handling and manufacturing processes, failure to follow raw material management procedures, and lack of established cleaning and validation protocols. These issues indicate a need for improved quality system controls and adherence to cGMP requirements.