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FDA Inspection
•Emergent Biodefense Operations Lansing LLC•September 29, 2021

Emergent Biodefense Operations Lansing LLC – FDA Inspection, Sep 29, 2021

Record Details

This FDA Inspection record concerns Emergent Biodefense Operations Lansing LLC, with an inspection on September 29, 2021, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
Emergent Biodefense Operations Lansing LLC
Inspection Date
September 29, 2021
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
View Company Profile

ID · 2a81b277-5b92-42d1-bf3e-ad2dcc46ca0d

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
1153937
FDA center
Biologics
Project area
Vaccines and Allergenic Products

FDA Citations

1
  1. 21 CFR 211.170(b)Reserve samples identified, representative, stored

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Emergent Biodefense Operations Lansing LLC

7
DateClassificationOfficeProject area
June 30, 2026Not classifiedDetroit District OfficeVaccines and Allergenic Products
December 13, 2023VAICenter for Biologics Evaluation and ResearchVaccines and Allergenic Products
September 27, 2018VAICenter for Biologics Evaluation and ResearchVaccines and Allergenic Products
April 19, 2016VAICenter for Biologics Evaluation and ResearchVaccines and Allergenic Products
November 14, 2013VAICenter for Biologics Evaluation and ResearchVaccines and Allergenic Products
View all 7 other inspections on the company page
Other documents for Emergent Biodefense Operations Lansing LLC
  • FDA Inspection 1312642 - 2026-06-30
  • FDA Inspection 1226835 - 2023-12-13
  • FDA Inspection 1069314 - 2018-09-27
  • FDA Inspection 964486 - 2016-04-19
  • FDA Inspection 859730 - 2013-11-14

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