# FDA 483 - Biogen MA Inc. - Unknown Date

Source: https://www.keypedia.com/records/483/biogen-ma-inc/23f788a7-37d4-47e1-94d6-8683aa9560a0

> FDA 483 for Biogen MA Inc. on Unknown Date. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Biogen MA Inc.
- Product Type: biologics
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Biogen, Inc. in RTP, NC, was inspected by the FDA, resulting in five observations related to significant deficiencies in their quality system. The inspection revealed failures in thoroughly investigating discrepancies, inadequate computer system controls, incomplete laboratory records, and issues with equipment logbook review and calibration records. These findings indicate a lack of robust controls over manufacturing and laboratory operations, particularly concerning data integrity and deviation management.

## 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 - 2021-06-16](https://www.keypedia.com/records/483/biogen-ma-inc/dfe6f839-66e9-4a58-a0a1-2ea8cf68f2b9)

## Related Officers

- [Cynthia Jim](https://www.keypedia.com/people/cynthia-jim/e0f1c8a7-d787-442a-911c-61e37cd806a6)

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