Viatris Pharmaceuticals LLC – FDA 483, May 18, 2026
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
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