# FDA 483 - Emergent Biodefense Operations Lansing LLC - December 12, 2026

Source: https://www.keypedia.com/records/483/emergent-biodefense-operations-lansing-llc/a47f076b-5061-41e4-92c1-541ec91dfc30

> FDA 483 for Emergent Biodefense Operations Lansing LLC on December 12, 2026. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Emergent Biodefense Operations Lansing LLC
- Inspection Date: 2026-12-12
- Product Type: biologics
- Office Name: Center for Veterinary Medicine
- Summary: An FDA inspection of BioPort Corporation in Lansing, MI, a biologics manufacturer, revealed several deficiencies related to manufacturing processes and quality control. Observations included incomplete validation of aseptic processes, lack of re-qualification procedures, and issues with validated manufacturing steps. Additionally, the firm lacked adequate written procedures for visual inspection defect limits, software operation, master batch production records, and reagent qualification.

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## Related Officers

- [Patsy J. Domingo](https://www.keypedia.com/people/patsy-j-domingo/40fb61e0-bfde-4e98-82e3-b0675d92cb86)
- [Deborah Tross](https://www.keypedia.com/people/deborah-tross/4bb1492a-9845-411e-9fea-390feaad67c6)
- [Bruce G. Meade](https://www.keypedia.com/people/bruce-g-meade/8682476b-9b55-4857-ad74-29a2341ff8a6)
- [Cynthia L. Kelley](https://www.keypedia.com/people/cynthia-l-kelley/daf490b4-150a-49d0-8f70-f4c43aea4709)

Company: https://www.keypedia.com/companies/emergent-biodefense-operations-lansing-llc/7a502584-4071-4f7a-bb11-7272db98f478

Office: https://www.keypedia.com/offices/center-for-veterinary-medicine/7e30a309-56e4-4e7a-8b8b-e07674bb07b4