Corza Medical Distribution GmbH, Austria Branch – FDA Inspection, Sep 12, 2025

Record Details

This FDA Inspection record concerns Corza Medical Distribution GmbH, Austria Branch, with an inspection on September 12, 2025, issued by the Office of Inspections and Investigations, covering biologics.

Company: Corza Medical Distribution GmbH, Austria Branch
Inspection Date: September 12, 2025
Product Type: Biologics
Office: Office of Inspections and Investigations
People: Priscilla M. Pastrana (Company Rep)
Richard L. Bartlett (Issuing Officer)

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ID · 8e68a7b0-fb82-443f-b086-64b9114ec32a

Inspection Facts

Inspection number: 1281428
FDA center: Biologics
Project area: Blood and Blood Products
Outcome: Form 483 issued, view the record

FDA Citations

21 CFR 211.160(a)Following/documenting laboratory controls
21 CFR 211.22(d)Procedures not in writing, fully followed
21 CFR 211.56(b)Written sanitation procedures lacking

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FDA Inspection

Corza Medical Distribution GmbH, Austria BranchSeptember 12, 2025