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FDA Inspection
•Gallant Medical, LLC.•September 5, 2025

Gallant Medical, LLC. – FDA Inspection, Sep 5, 2025

Record Details

This FDA Inspection record concerns Gallant Medical, LLC., with an inspection on September 5, 2025, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
Gallant Medical, LLC.
Inspection Date
September 5, 2025
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
Person
  • Emily B. Camire (Issuing Officer)
View Company Profile

ID · 4e0398ae-0ad3-4fcf-b1a1-0f4bf30e5877

Inspection Facts

No Action Indicated (NAI)

No objectionable conditions or practices were found during the inspection.

Inspection number
1280589
FDA center
Biologics
Project area
Human Cellular, Tissue, and Gene Therapies

Other FDA inspections of Gallant Medical, LLC.

3
DateClassificationOfficeProject area
November 30, 2018NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
March 30, 2016NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
April 11, 2013VAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
Other documents for Gallant Medical, LLC.
  • FDA Inspection 1076318 - 2018-11-30
  • FDA Inspection 980779 - 2016-03-30
  • FDA Inspection 827057 - 2013-04-11

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