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

Source: https://www.keypedia.com/records/483/biogen-us-corporation/726781bf-1eb0-471e-85bb-fc1952ea7a7d

> FDA 483 for Biogen U.S. Corporation on December 09, 2022. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Biogen U.S. Corporation
- Inspection Date: 2022-12-09
- Product Type: Drugs
- Office Name: Office of Compliance and Biologics Quality
- Summary: 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

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Company: https://www.keypedia.com/companies/biogen-us-corporation/515ce53c-77be-414c-bcf4-c66be60b098e

Office: https://www.keypedia.com/offices/office-of-compliance-and-biologics-quality/5592f0a1-da8d-4887-bad6-2f16ea7451a0