Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistCarolina Infusion, a compounding pharmacy, was found to have produced drug products that violated federal law by failing to meet the exemption conditions under Section 503A of the Federal Food, Drug, and Cosmetic Act. The FDA identified serious deficiencies in the company's practices for producing both non-sterile and sterile drug products, including a lack of sterility assurance that put patients at risk. The company voluntarily recalled all sterile products within expiry and ceased production of intrathecal medications following an FDA inspection conducted from July to August 2022.