# FDA 483 - EMERGENT BIO-DEFENSE, INC. - March 11, 2008

Source: https://www.keypedia.com/records/483/emergent-bio-defense-inc/1362e3e3-e4fe-466c-9b18-d3125a3bb1c4

> FDA 483 for EMERGENT BIO-DEFENSE, INC. on March 11, 2008. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: EMERGENT BIO-DEFENSE, INC.
- Inspection Date: 2008-03-11
- Product Type: biologics
- Office Name: Center for Veterinary Medicine
- Summary: The FDA inspection of Emergent Bio-Defense, Inc. in Lansing, MI, revealed significant deficiencies across its anthrax vaccine manufacturing operations. Issues included inadequate investigations into deviations and product contamination, insufficient documentation for manufacturing processes and quality control, and a lack of validation data for critical steps like sterile filtration and media storage. These findings indicate a systemic failure in maintaining robust quality systems and ensuring product quality and safety.

Company: https://www.keypedia.com/companies/emergent-bio-defense-inc/471da5b9-f3c7-495a-b04f-6d140a7a8a97

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