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American Specialty Pharmacy, Inc. dba ASP Cares, a registered outsourcing facility, produced sterile compounded drug products that failed to meet the conditions required under section 503B of the Federal Food, Drug, and Cosmetic Act (FDCA) to qualify for exemptions from drug approval and labeling requirements. During an FDA inspection conducted August 14-23, 2018, investigators identified serious deficiencies in the facility's practices for producing sterile drug products that put patients at risk and violated FDCA requirements. The company's responses to an FDA Form 483 and subsequent information request in 2018-2019 were insufficient to resolve the documented compliance failures.