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Warning letters, 483s, Recalls, Import Alerts, Audit observations
Warning letters, 483s, Recalls, Import Alerts, Audit observations
South Korean Drug Regulator MFDS imposed administrative penalties on GlaxoSmithKline (GSK), reports Korea Bio Medical Review. The penalties are for violation of regulations Pharmaceutical Affairs Act and Rules on the Safety of Pharmaceuticals and Other Drugs. According to the MFDS GSK failed to report changes in the specifications of the main ingredient in the active pharmaceutical ingredient (API). Violation was found related to the Fluticasone products for Asthma treatment Seretide and Flixotide. The penalties include fine of 52.2 million won ($37,680) and six month import suspension.
MFDS (Ministry of Food and Drug Safety) is the agency responsible for regulation of drugs, medicinal products, medical devices in South Korea.
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