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Fagron Compounding Services, an outsourcing facility registered to produce sterile drug products, produced adulterated drugs that failed to meet the conditions required under section 503B of the Federal Food, Drug, and Cosmetic Act, thereby losing exemptions from standard drug approval requirements. During a June 2024 FDA inspection, investigators identified serious deficiencies in the facility's practices for producing sterile drug products that put patients at risk, including lack of sterility assurance in compounded medications. The company had already initiated a voluntary recall of four lots of Lidocaine HCl Injection, 2% in August 2024 due to sterility concerns, and submitted multiple responses to FDA's Form 483 observations between July and October 2024.