Alvotech — FDA 483 Findings

The SOPs for Deviation handling, Handling of Product Quality Complaints, Handling of OOS, OOT and OOE results lack clarity on the period of each extension and the times of extensions for the cases that cannot be closed during the original targeted period.

The PTS endosafe endotoxin detection method used to detect endotoxin in in-process, and drug substance and drug product release samples was not adequately qualified and the sample preparation is inadequate.

Inventory and analysis of raw materials are inadequate.

The microbial ingress risk during recurring drug substance and drug product in-process is not adequately mitigated.

Investigations of an unexplained discrepancy did not extend to other drug products that may have been associated with the specific failure or discrepancy.

Procedures to control environmental conditions have not been adequately established.

The specifications for the incoming stoppers from are inadequate.

The accuracy of test methods has not been established and documented.

Your firm lacks procedural control to ensure that incoming materials are adequately qualified.

The incoming material are released for manufacturing operations prior to completing the final testing.

The stopper defects were not appropriately classified.

The manufacturing areas are not under control for bacteria and mold.