FDA 483 - BSO LLC - March 11, 2021

An FDA inspection of BSO LLC, an outsourcing facility in Lakewood, CO, revealed significant deficiencies across multiple operational areas. The firm failed to conduct thorough investigations into environmental monitoring excursions and lacked adequately detailed procedures for equipment cleaning and maintenance. Additionally, drug product labels were found to be missing required ingredient information, and the facility was compounding drugs that are essentially copies of approved drugs.