# Emergent Biodefense Operations Lansing LLC – FDA 483, Nov 5, 2013

Source: https://www.keypedia.com/records/483/emergent-biodefense-operations-lansing-llc/76eff22a-c687-4f53-a2dc-a4885efa4f5c

> FDA 483 for Emergent Biodefense Operations Lansing LLC on November 05, 2013. 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: 2013-11-05
- Product Type: biologics
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Emergent BioDefense Operations Lansing, LLC in Lansing, MI, revealed numerous deficiencies across its manufacturing and quality systems. Key issues include inadequate environmental monitoring, unvalidated QC methods, insufficient material storage controls, and a lack of adherence to and formalization of standard operating procedures. These findings indicate a need for comprehensive corrective actions to ensure product quality and regulatory compliance.

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## Related Officers

- [Chemist](https://www.keypedia.com/people/chemist/4f859dce-4065-49a2-8213-7875fcef7211)
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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/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1