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Talk to a SpecialistTalk to a SpecialistAdvanced Nutriceuticals, LLC dba The Guyer Institute of Molecular Medicine, a compounding pharmacy, was cited for producing adulterated drug products that failed to meet the exemption conditions under Section 503A of the Federal Food, Drug, and Cosmetic Act. FDA investigators documented serious deficiencies in the facility's practices for producing sterile drug products, including failures to comply with current good manufacturing practice (CGMP) requirements, which put patients at risk. The company voluntarily ceased sterile production operations and initiated a recall of all compounded sterile products due to lack of sterility assurance.