# FDA 483 - Biogen MA Inc. - June 16, 2021

Source: https://www.keypedia.com/records/483/biogen-ma-inc/dfe6f839-66e9-4a58-a0a1-2ea8cf68f2b9

> FDA 483 for Biogen MA Inc. on June 16, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Biogen MA Inc.
- Inspection Date: 2021-06-16
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Biogen Inc.'s drug substance manufacturing facility in Research Triangle Park, NC, revealed significant deficiencies across multiple quality systems. Observations included inadequate documentation for training samples, poor maintenance of equipment and facilities, and failures in contamination control. The firm also lacked complete method validation for bioburden detection, had an inadequately specified GMP utility, and demonstrated non-adherence to several standard operating procedures.

## Related Documents

- [483 - 2013-08-02](https://www.keypedia.com/records/483/biogen-ma-inc/22089221-f89b-43ed-a969-cccdaae86c05)
- [483 - 2017-03-23](https://www.keypedia.com/records/483/biogen-ma-inc/0ef5ddec-ecba-4594-b6ca-f236d7d71dde)
- [483 - Unknown Date](https://www.keypedia.com/records/483/biogen-ma-inc/23f788a7-37d4-47e1-94d6-8683aa9560a0)

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/zhao-wang/51081e23-1891-4c93-9488-f578511e0a0e)
- [Senior Regulatory Specialist](https://www.keypedia.com/people/wayne-e-seifert/e92e1f10-c61e-4b08-9156-25907e5e2942)

Company: https://www.keypedia.com/companies/biogen-ma-inc/85b778d2-1e69-485d-9e93-05c656646fa2

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd