FDA EIR - Cambrex Profarmaco Milano Srl - November 11, 2022

An FDA Post-Approval Inspection (PoAI) of Cambrex Profarmaco Milano Srl, an active pharmaceutical ingredient (API) manufacturer, was conducted from November 7 to November 11, 2022. The inspection, part of a foreign inspection trip, was performed under Compliance Program 7356.843 (Post-Approval Audit Inspection). Its purpose was to verify activities such as change controls for manufacturing process modifications, commercial batch history, and laboratory testing. Notably, no formal observations (FDA-483) were issued during this inspection, nor during the previous inspection in May 2019. One minor verbal observation regarding a specific manufacturing step was discussed with the firm's management. The inspection concluded with a "No Action Indicated" (NAI) classification, meaning no immediate corrective actions are mandated. The facility is scheduled for re-inspection as per future assignments.