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

Source: https://www.keypedia.com/records/483/emergent-bio-defense-inc/5beb6759-aaa1-41cb-b8e9-3e81ae8fc3fa

> 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: An FDA inspection of Emergent Bio-Defense, Inc. in Lansing, MI, revealed significant deficiencies in their anthrax vaccine manufacturing processes. Key issues included inadequate and untimely investigations into deviations and contaminations, incomplete documentation for manufacturing processes, and a lack of validation data for critical steps like sterile filtration and media preparation. The firm also demonstrated poor control over labeling, warehouse identification, water systems, and complaint handling, indicating a broad pattern of non-compliance with GMP regulations.

Company: https://www.keypedia.com/companies/emergent-bio-defense-inc/bc0e9f4e-3b90-4a89-8b20-786501921307

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