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Talk to a SpecialistTalk to a SpecialistTailstorm Health Inc. dba Medivant Health, a registered outsourcing facility, produced sterile drug products that failed to meet the conditions required under section 503B of the Federal Food, Drug, and Cosmetic Act, with serious deficiencies in manufacturing practices for sterile drugs that put patients at risk. During an FDA inspection from September 24 to October 10, 2024, investigators found evidence that the company's products did not qualify for exemptions from drug approval requirements, and the firm subsequently initiated a voluntary recall of multiple lots of compounded Bevacizumab due to lack of sterility assurance. The FDA determined that the company produced drugs in violation of the FDCA based on these manufacturing and quality control failures.