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

This FDA inspection report details a post-approval audit of Cambrex Profarmaco Milano Srl, an active pharmaceutical ingredient (API) manufacturer, conducted from November 7 to November 11, 2022. The inspection was performed under Compliance Program 7356.843 (Post-Approval Audit Inspection), focusing on verifying change controls for manufacturing process modifications, commercial batch history, and laboratory testing. Notably, the inspection concluded without the issuance of an FDA-483, indicating no formal written observations of regulatory non-compliance. A single verbal observation was discussed with the firm's management during the close-out meeting, concerning a specific step in the manufacturing process. Overall, the facility continues to operate as an API manufacturer. The inspection outcome was classified as "No Action Indicated (NAI)," meaning no regulatory actions are required from the company based on this inspection. The report recommends re-inspection as part of future assignments, a standard practice for ongoing oversight. No samples were collected, and no refusals were encountered during the inspection.