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

Source: https://www.keypedia.com/records/483/emergent-biodefense-operations-lansing-llc/3375d8b8-f81f-4248-accc-4bbf8f8b294f

> 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 Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Emergent BioSolutions in Lansing, MI, from September 30 to October 4, 2019, identified two significant observations. The firm was cited for inadequate segregation in a manufacturing area and the absence of a written procedure for the use and control of certain materials. These findings suggest deficiencies in facility control and procedural documentation.

## Related Documents

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## Related Officers

- [Steven Derrick](https://www.keypedia.com/people/steven-derrick/02f4d33d-eb6a-417e-803e-969610fda7f6)
- [David Bentley](https://www.keypedia.com/people/david-bentley/11c47d3f-04a5-4962-8417-073e845c7783)
- [Jennifer Bridgewater](https://www.keypedia.com/people/jennifer-bridgewater/1db4c734-5553-4773-a5a5-1e6049db3a51)
- [Christine Harman](https://www.keypedia.com/people/christine-harman/916fa691-117d-446b-8b53-7413194e3eda)

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

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd