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the FDA noted that repeated lapses demonstrate that executive management oversight and control over drug manufacture are inadequate and directed Empower to engage a third-party consultant with sterile drug manufacturing expertise State actions at least a dozen states have brought actions against Empower within the last decade, including a California State Board of Pharmacy disciplinary order Eli Lilly lawsuits Eli Lilly filed two separate lawsuits against Empower: one in April 2025 and another in July 2025, alleging unlawful manufacturing and misleading marketing of tirzepatide products

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