Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistSoliteint Kozmetikai KFT, a Hungarian drug manufacturer, violated Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, specifically failing to conduct adequate laboratory testing of over-the-counter external analgesic products for identity and strength of active ingredients prior to release and distribution. The FDA inspection from April 15-19, 2024 found that the company did not perform appropriate testing to confirm batches met final specifications or were free of objectionable microorganisms, rendering their drug products adulterated. The company's May 2024 response to the FDA's Form 483 inspection findings was deemed inadequate due to insufficient corrective action documentation and evidence of compliance efforts.