# FDA 483 - Corza Medical Distribution GmbH, Austria Branch - September 12, 2025

Source: https://www.keypedia.com/records/483/corza-medical-distribution-gmbh-austria-branch/d5971d89-6d04-40d4-9a8a-d28e1ba59b0a

> FDA 483 for Corza Medical Distribution GmbH, Austria Branch on September 12, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Corza Medical Distribution GmbH, Austria Branch
- Inspection Date: 2025-09-12
- Product Type: biologics
- Office Name: Division of Blood Components and Devices
- Summary: Corza Medical Distribution GmbH, Austria Branch, a licensed combination product manufacturer, was cited with three observations during an FDA inspection. The firm failed to follow established test procedures, specifically using expired reagents for standard curves for TachoSil product batches distributed in the US. Additionally, the quality control unit did not consistently follow procedures for timely deviation initiation and OOS closure, and lacked detailed written sanitation procedures for manufacturing rooms.

## Related Documents

- [483 - 2025-09-12](https://www.keypedia.com/records/483/corza-medical-distribution-gmbh-austria-branch/c99c08ce-3aa6-47a1-a9cd-f99ac1336542)

## Related Officers

- [Richard L. Bartlett](https://www.keypedia.com/people/richard-l-bartlett/602337b9-ac77-41bb-a254-71a9d345335b)
- [investigator](https://www.keypedia.com/people/priscilla-m-pastrana/170080d1-49da-42d7-8615-c774cac9f7ec)

Company: https://www.keypedia.com/companies/corza-medical-distribution-gmbh-austria-branch/5c01fea4-9e27-463c-86d2-5f1e57a2ddf7

Office: https://www.keypedia.com/offices/division-of-blood-components-and-devices/02cc5ccf-d21e-445f-91e7-474736bc8917