Viatris Inc. – FDA 483, Jul 25, 2019

An FDA inspection of Mylan Pharmaceuticals Inc. in Morgantown, WV, revealed significant and recurring deficiencies across its human drug manufacturing operations. Issues included inadequate investigations into out-of-specification results and stability failures, widespread cleaning validation and equipment maintenance problems, and a failure of the Quality Unit to follow established procedures and ensure timely closure of critical events. These observations indicate systemic control and quality assurance breakdowns impacting multiple drug products.