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Talk to a SpecialistTalk to a SpecialistInfusion Options, Inc., an outsourcing facility that compounds sterile drug products, was cited for failing to meet the conditions required under section 503B of the Federal Food, Drug, and Cosmetic Act and for serious deficiencies in sterile drug product manufacturing practices that put patients at risk. FDA inspections conducted from May to June 2019 identified violations at both the facility and its warehouse location in Brooklyn, New York. In response, the company voluntarily recalled all sterile products within expiry due to lack of sterility assurance and permanently discontinued 503B compounding operations on June 11, 2019, followed by de-registration as an outsourcing facility on July 5, 2019.