Form 483

Emergent Biodefense Operations Lansing LLC Form 483, 2026-06-30

FDA issued a Form 483 to Emergent Biodefense Operations Lansing LLC on 2026-06-30 with 1 public-safe observation.

483· Form 483 issuedBiologics1 observation

Emergent Biodefense Operations Lansing LLC · Lansing, United States · Issued June 30, 2026

Overview

  • 1 public-safe observation is available for this inspection.
  • 1 structured CFR citation is represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

30 Jun 2026
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Matthew J Gretkierewicz, Christian Lynch

Inspected site

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.100(a)Cited across public-safe Form 483 observations1x

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  • The site's full inspection history around this Form 483
  • Whether these citations escalated to a warning letter
  • The investigators involved and the citations they repeat elsewhere