# FDA 483 - Emergent Biodefense Operations Lansing LLC - December 01, 2009

Source: https://www.keypedia.com/records/483/emergent-biodefense-operations-lansing-llc/d5a2e0a5-acc2-4642-82ee-03936d62b101

> FDA 483 for Emergent Biodefense Operations Lansing LLC on December 01, 2009. 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: 2009-12-01
- Product Type: biologics
- Office Name: Center for Veterinary Medicine
- Summary: An FDA inspection of Emergent BioDefense Operations Lansing Inc. in Lansing, MI, a vaccine manufacturer, revealed significant deficiencies across multiple areas of its BioThrax® and Anthrax vaccine production. Key issues included inadequate handling of out-of-specification results, failures in aseptic processing, and a lack of proper documentation and procedures for critical manufacturing and quality control activities. The findings indicate a need for improved quality unit oversight, robust investigation processes, and adherence to sterile manufacturing protocols.

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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