FDA 483 - Bora Pharmaceuticals Inc. - July 11, 2024

An FDA inspection of Upsher Smith Laboratories, LLC in Maple Grove, MN, revealed significant deficiencies in their manufacturing processes. Observations included inadequate testing of drug product components for harmful substances like diethylene glycol, and failure to follow written procedures for equipment cleaning and maintenance. Additionally, the firm's batch records lacked proper documentation for equipment identification, indicating a lack of control over critical aspects of drug manufacturing and quality.