The Ministry of Food and Drug Safety (MFDS) released the results of its regular GMP (Good Manufacturing Practice) inspection of Kyungbang Shinyak's drug manufacturing plant. According to data recently posted on Drug Safety Nation, the inspection identified seven observations related to facility equipment and manufacturing processes. All seven items were classified under the PIC/S standard as "Other." One observation has already been corrected, and the remaining six were deemed acceptable based on the company's submitted implementation plan. No major or critical observations were found, so no administrative penalties will be imposed. Under MFDS guidelines, "Other" observations are subject to corrective actions and remediation.
Regulatorische Updates17. Sept. 2026•3 Min. Lesezeit
MFDS reports 7 GMP observations for Kyungbang Shinyak, all classified as "Other"
The Ministry of Food and Drug Safety disclosed that Kyungbang Shinyak received seven GMP observations in facility equipment and manufacturing, all categorized as "Other" with no major issues.
Zusammengestellt vom Pharmacountry-Team · Quelle: KPA News
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