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United States District Court Central District of Calfornia USA v Hubei Aoks Bio-Tech Co and Xuening Gao et al Indictment Filed May 10, 2024 Read the document.
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On August 14, 2024, FDA received a complaint from a patient who noticed a black particulate in a vial of semaglutide distributed by Fullerton Wellness. On September 23, 2024, FDA received information from California regulatory authorities as part of ongoing collaboration between FDA and the state noting deficiencies found at Fullerton Wellness during a state inspection. After the state inspection, Fullerton Wellness voluntarily ceased operations.
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The agency urges manufacturers, including repackagers, to clearly identify any ingredients intended for use in foods or dietary supplements on the label. Providing this information on ingredient labels could help prevent compounders from using ingredients that are not appropriate for sterile drugs and may help prevent patient harm.
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This week the agency warned about compounding safety and sterility issues and a newly posted document shows inspectors enforcing manufacturing standards.
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