FDA 483 - Viatris Pharmaceuticals LLC - May 18, 2026
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Viatris Pharmaceuticals LLC in Vega Baja, PR, was cited for significant quality control and manufacturing deficiencies. The inspection revealed that drug products were released without adequate nitrosamine impurity testing, and out-of-specification investigations were not thoroughly conducted or accurately reported. Additionally, the facility experienced multiple insect infestations in manufacturing areas, and the firm failed to follow its own procedures for timely completion of investigations and CAPAs.
ID · 14934639-1ca7-4615-a289-4a87365293cb