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

Source: https://www.globalkeysolutions.net/records/483/emergent-biodefense-operations-lansing-llc/90f884c5-df6f-416f-9716-60c95553ca37

> 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: Center for Veterinary Medicine
- Summary: An FDA inspection of Bioport Corporation, a vaccine manufacturer in Lansing, Michigan, revealed significant quality system deficiencies. The firm failed to conduct complete investigations into manufacturing failures and deviations, maintain equipment properly, and ensure the timely implementation and tracking of corrective actions. Additionally, issues were noted with computer system qualification, visual inspection criteria, and the completeness and timeliness of Annual Product Reviews.

## 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/48c29888-dcd9-48f1-9b76-e0d47aebf340)
- [483 - Unknown Date](https://www.globalkeysolutions.net/records/483/emergent-biodefense-operations-lansing-llc/9d025569-43d9-4be6-9a2f-2d4d2ae68e8c)

## Related Officers

- [Horace D. Meade](https://www.globalkeysolutions.net/people/horace-d-meade/a43a68ea-bf30-4345-a2de-4afcd97d0975)
- [investigator](https://www.globalkeysolutions.net/people/jacqueline-m-diaz-albertini/9ff937fe-4e9b-445a-80fa-e26800d923b8)
- [Ann Marie Schofield](https://www.globalkeysolutions.net/people/ann-marie-schofield/7f4d817e-cdde-4578-bd26-2280ed570b76)

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

Office: https://www.globalkeysolutions.net/offices/center-for-veterinary-medicine/7e30a309-56e4-4e7a-8b8b-e07674bb07b4