# FDA 483 - Biogen MA Inc. - August 02, 2013

Source: https://www.keypedia.com/records/483/biogen-ma-inc/22089221-f89b-43ed-a969-cccdaae86c05

> FDA 483 for Biogen MA Inc. on August 02, 2013. Product: N/A. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Biogen MA Inc.
- Inspection Date: 2013-08-02
- Office Name: Atlanta District Office
- Summary: This FDA Form 483 document details observations from an inspection of manufacturing and control operations for the APIs Tysabri (natalizumab) and Avonex (Interferon Beta 1a).

**Observation 1:** The firm lacks assurance that it consistently challenges the validity of testing results provided in container-supplier's certificates of analysis as part of supplier qualification. Specifically, bulk bags used for Tysabri API, certified as sterile and endotoxin-free, have never had these results challenged or verified by the firm.

**Observation 2:** The firm fails to adequately and/or completely document the execution of control procedures in equipment logbooks and/or production records, raising questions about adherence to procedures. Examples include:
*   Logbooks for biosafety hoods in Avonex and Tysabri production rooms do not document cleaning/sanitizing agents used or contact times.
*   The logbook for the Bio-Reactor # used in Tysabri API production lacks documentation of buffers used to standardize pH-measuring probes.
*   The logbook for the chromatography column skid in Tysabri API purification does not document values obtained during standardization of UV and conductivity probes.
*   The Tysabri API batch production record only states the UV meter of the System was standardized, without documenting the value obtained as per procedure PRCD-19494.
*   Questionable logbook entries were found for biosafety hood #, where entries

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## Related Officers

- [Seneca D. Toms](https://www.keypedia.com/people/seneca-d-toms/3eda62a2-4c12-438f-805a-5e3efb0f2f94)
- [Jose A. Cruz Gonzalez](https://www.keypedia.com/people/jose-a-cruz-gonzalez/a005cff1-0a90-4396-82c4-de4b0a579374)

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

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7