FDA向配制药企Empower Pharmacy发出警告信,指其违规仿制已获批的GLP-1药物,并因生产设施存在不卫生条件引发无菌担忧。FDA表示将继续对不遵守联邦法律的企业采取行动,以保护患者免受劣质配制GLP-1药物影响。
原文披露了警告信针对仿制已获批GLP-1药物与无菌生产条件两项缺陷,可了解FDA对配制药企的执法口径。
FDA issued a warning letter to a compounder citing violations based on making copies of FDA-approved GLP-1 drugs. The warning letter to Empower Pharmacy also cites sterility concerns because their drugs were made in a facility where FDA observed insanitary conditions.
FDA is committed to protecting patients from poor quality compounded GLP-1 drugs and will continue taking action when companies fail to follow federal law. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/empower-clinic-services-llc-dba-empower-pharmacy-738238-09182026
来源:U.S. FDA · x.com