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

Source: https://www.globalkeysolutions.net/records/483/emergent-biodefense-operations-lansing-llc/48c29888-dcd9-48f1-9b76-e0d47aebf340

> 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: The inspection of Emergent BioDefense Operations, LLC in Lansing, Michigan, revealed significant deficiencies in the firm's quality control unit. The observations primarily concern inadequate oversight of contract fillers, lack of proper review for potential quality problems, insufficient quarantine procedures, undefined change control effectiveness checks, and incomplete impact assessments. These issues indicate a systemic failure in ensuring product quality and compliance with cGMP regulations.

## Related Documents

- [483 - 2019-10-04](https://www.globalkeysolutions.net/records/483/emergent-biodefense-operations-lansing-llc/5c223598-5b5c-473d-87e5-b838c4f5abf3)
- [483 - 2026-12-12](https://www.globalkeysolutions.net/records/483/emergent-biodefense-operations-lansing-llc/a47f076b-5061-41e4-92c1-541ec91dfc30)
- [483 - Unknown Date](https://www.globalkeysolutions.net/records/483/emergent-biodefense-operations-lansing-llc/3375d8b8-f81f-4248-accc-4bbf8f8b294f)
- [483 - Unknown Date](https://www.globalkeysolutions.net/records/483/emergent-biodefense-operations-lansing-llc/9d025569-43d9-4be6-9a2f-2d4d2ae68e8c)
- [483 - 2013-11-05](https://www.globalkeysolutions.net/records/483/emergent-biodefense-operations-lansing-llc/76eff22a-c687-4f53-a2dc-a4885efa4f5c)

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/jean-hu-primmer/55300298-db2a-4ee9-b4cf-de5623c69013)
- [Gene Ancy, CSO](https://www.globalkeysolutions.net/people/gene-ancy-cso/9669dbe9-bc11-426f-940b-c9b70f94448e)

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