# FDA 483 - Emergent Biodefense Operations Lansing LLC - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/emergent-biodefense-operations-lansing-llc/9d025569-43d9-4be6-9a2f-2d4d2ae68e8c

> FDA 483 for Emergent Biodefense Operations Lansing LLC on Unknown Date. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Emergent Biodefense Operations Lansing LLC
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: An FDA inspection of Emergent BioDefense Operations Lansing, LLC's vaccine manufacturing facility revealed significant deficiencies across multiple quality systems. The firm failed to adequately document deviations, qualify raw materials, support expiration dates, control environmental contamination by Bacillus anthracis, and ensure effective cleaning validation. These issues indicate a broad lack of control over manufacturing processes, documentation, and investigations for products like BioThrax and Anthrax Vaccine Absorbed.

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## Related Officers

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

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0