# Emergent Biodefense Operations Lansing LLC – FDA 483, Jun 30, 2026

Source: https://www.keypedia.com/records/483/emergent-biodefense-operations-lansing-llc/676663f4-639c-418a-b299-2a0d3caab5af

> FDA 483 for Emergent Biodefense Operations Lansing LLC on June 30, 2026. 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: 2026-06-30
- Product Type: biologics
- Office Name: Detroit District Office
- Summary: Emergent Biodefense Operations Lansing LLC in Lansing, MI, was inspected regarding its licensed biologics manufacturing. The inspection revealed significant failures in establishing adequate written procedures for production and process controls, leading to recurring quality issues and the rejection of numerous CYFENDUS drug product lots. These issues indicate a severe lack of control over product quality, purity, and identity.

## Related Documents

- [483 - 2023-12-13](https://www.keypedia.com/records/483/emergent-biodefense-operations-lansing-llc/5a6b8474-3a19-4b56-ad4e-8317f1065f27) — date: December 13, 2023
- [483 - 2021-09-29](https://www.keypedia.com/records/483/emergent-biodefense-operations-lansing-llc/897aede3-ab80-4bab-86b4-583db5c1bc99) — date: September 29, 2021
- [483 - 2019-10-04](https://www.keypedia.com/records/483/emergent-biodefense-operations-lansing-llc/5c223598-5b5c-473d-87e5-b838c4f5abf3) — date: October 4, 2019
- [EIR - 2018-09-27](https://www.keypedia.com/records/eir/emergent-biodefense-operations-lansing-llc/c06aeb7e-a20d-4ddb-915e-dd7065229dfc) — date: September 27, 2018
- [483 - 2016-04-12](https://www.keypedia.com/records/483/emergent-biodefense-operations-lansing-llc/5507cc83-bd28-405f-bd89-2a8b07648040) — date: April 12, 2016

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/matthew-j-gretkierewicz/d2b43230-5324-44e0-9cd0-7e40464bf5b0)
- [Christian Lynch](https://www.keypedia.com/people/christian-lynch/ee342d8e-9fcf-4c84-9494-ceaf6320faf6)

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

Office: https://www.keypedia.com/offices/detroit-district-office/b09a1815-a000-40c0-bb44-5432ce87ed03