FDA 483 - Pharmacia & Upjohn Company LLC - June 16, 2023

Pharmacia & Upjohn Company LLC in Kalamazoo, MI, a drug and biologic manufacturer, was cited for multiple significant deficiencies during an FDA inspection. The observations primarily concern inadequate production and process controls, unsuitable facility construction, insufficient quality unit oversight, and deficiencies in aseptic process validation, equipment design, and facility sanitation, all of which pose risks to product quality and sterility.