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FDA asked Medline Industries to respond to its warning letter within 15 business days and noted that since the December 2025 inspection, the agency has updated its Quality System (QS) regulation to the Quality Management System Regulation (QMSR) to harmonize with international regulatory standards

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[DOI] [PMC free article] [PubMed] [Google Scholar] 14.Gorenec L., Zidovec Lepej S., Grgic I., Planinic A., Iscic Bes J., Vince A., Begovac J