FDA 483 - Viatris Pharmaceuticals LLC - August 20, 2013

The FDA inspection of Pfizer Pharmaceuticals LLC revealed significant deficiencies across multiple areas of its pharmaceutical manufacturing operations. Key issues include inadequate complaint handling, incomplete investigations into discrepancies and batch failures, untimely submission of Field Alert Reports, and a lack of complete and scientifically sound laboratory controls, including stability testing, impurity evaluation, and instrument calibration. Additionally, master batch records, cleaning procedures, equipment maintenance records, and computer system data integrity were found to be deficient, indicating systemic failures in quality control and documentation practices.