FDA 483 - Biogen U.S. Corporation - December 09, 2022

On December 5-9, 2022, the FDA inspected Biogen U.S. Corporation, a drug product manufacturer located at 900 Davis Drive, Research Triangle Park, NC. The inspection revealed several observations regarding production, process controls, contamination prevention, and document control.

**Key Observations:**

1. **Failure to follow written production and process control procedures:** * On December 6, 2022, during Factor VIII XTEN filling, a broken vial was observed. Operators did not immediately stop the line as per SOP PRCD-61637, instead attempting to remove the vial while the line continued for 5-6 minutes. * A partial tray of Factor VIII XTEN, batch# (b) (4), 500 IU, was incorrectly packed and labeled before cold room storage.

2. **Lack of procedures to prevent contamination:** * On December 6, 2022, manufacturing personnel removed a protective cover to clear a lodged vial, exposing adjacent vials to a Grade (b) (6) environment and potential particulate contamination. No risk assessment or procedure exists for this intervention.

3. **Insufficient document control by the Quality Unit:** * Blank test forms used by the Quality Control laboratory for in-process and release testing lacked sequential numbering or unique identifiers and were not tracked or reconciled. * Access