Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistUS Specialty Formulations, LLC, a registered outsourcing facility (compounding pharmacy), was warned for producing sterile drug products that failed to meet the conditions required under section 503B of the Federal Food, Drug, and Cosmetic Act, creating patient safety risks. During an FDA inspection from March to April 2022, investigators identified serious deficiencies in the facility's practices for producing drugs intended to be sterile, including inadequate sterility assurance that led the company to voluntarily recall certain products in May 2022. The facility's drug products violated the FDCA by failing to qualify for the exemptions from drug approval requirements that outsourcing facilities are permitted to claim.