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Hair was observed: In stopper areas In proximity to the product In some cases, in direct contact with a sterile drug product Affected: Multiple drug products Multiple customers Both before and after Novo Nordisk acquisition Investigations: Were not initiated in a timely manner Lacked supporting data for assigned root causes Were not expanded to include potentially impacted batches or products Failed to assess CAPA effectiveness Trending: Ineffective due to restricted search terms and limited timeframes defined in procedures Batch disposition: Contaminated units were culled Remaining units were released Customers later reported the same contamination in the received product At least (b)(4) batches associated with mammalian hair were released post-acquisition Media Fill Failures More than five media fill batches have been terminated since November 2023

Article versions Submission history Received : 3 March 2025 Resubmitted : 4 July 2025 Accepted : 25 July 2025 Published online : 19 August 2025 Acknowledgments Funding: This study was supported by the Medical and Health Project Program of Zhejiang Province (2024KY008, 2023KY028, and 2023KY035), a Zhejiang Traditional Chinese Medicine Administration Program grant (2023ZL242), and the Pioneer and Leading Goose technology projects of Zhejiang Province (2024C03094)

Another very important liver function is helping the immune system fight infections and removing toxins from the blood stream