FDA 483 - Viatris Pharmaceuticals LLC - February 17, 2022

Pfizer Pharmaceuticals LLC in Vega Baja, PR, was cited for failing to ensure that drug products conform to final specifications prior to release. Specifically, the firm's Quality Unit did not adequately control for potential genotoxic N-Nitrosamine impurities, such as Nitrosodiethanolamine (NDELA), in Atorvastatin API used for Lipitor and Atorvastatin Calcium Tablets. This issue stemmed from an insufficient risk assessment and reliance on supplier testing without confirmatory testing for all batches, despite identified risks.