# FDA 483 - Emergent Biodefense Operations Lansing LLC - September 29, 2021

Source: https://www.keypedia.com/records/483/emergent-biodefense-operations-lansing-llc/897aede3-ab80-4bab-86b4-583db5c1bc99

> FDA 483 for Emergent Biodefense Operations Lansing LLC on September 29, 2021. 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: 2021-09-29
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: An FDA inspection of Emergent BioDefense Operations Lansing LLC in Lansing, MI, revealed that the firm's reserve drug product samples were not representative of each lot or batch. This issue stemmed from an inadequate sample collection plan and a deficient standard operating procedure (SOP) for retention sampling. The firm failed to collect samples throughout the entire production lot for products like BioThrax® and AV7909.

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## Related Officers

- [investigator](https://www.keypedia.com/people/brantley-s-collins/c806aac1-3d89-4427-8aeb-6d9db6dfc2f4)
- [Team Biologics Staff](https://www.keypedia.com/people/linda-thai/f4d9a1c3-e5e8-4f13-8abe-e1f1e597c8f8)

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

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