FDA 483 - Viatris Pharmaceuticals LLC - January 26, 2018

Pfizer Pharmaceuticals LLC in Vega Baja, PR, was cited for failing to thoroughly review unexplained discrepancies during an inspection from January 10-26, 2018. Specifically, the firm did not adequately investigate critical defects like broken Nitrostat tablets in distributed lots. The investigation was incomplete, as it failed to evaluate manufacturing process parameters and lacked proper user permission controls for critical system parameters.