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[1] Tirzepatide may cause fetal harm and should be discontinued at least 2 months before a planned pregnancy

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At least two terminations: Related to stoppering issues and extrinsic particles Were not captured as deviations at the time of occurrence Media fills were re-executed and accepted: Without documented root cause analysis Without documented CAPA implementation Without evaluation of aseptic control failure modes SEE ALSO: Media Fill Tests: Aseptic Process Simulation (APS) in Sterile Manufacturing FDA’s Core Concern The firm repeatedly relied on passing sterility, endotoxin, and environmental monitoring results to justify the conclusion that no product impact existed