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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
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[DOI] [PMC free article] [PubMed] [Google Scholar] 181.Wu Y., Hu Y.L., Liu W., Sun B.J., Zhang C.F., Wu L.L., Liu T.H
