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

Source: https://www.keypedia.com/records/483/corza-medical-distribution-gmbh-austria-branch/c99c08ce-3aa6-47a1-a9cd-f99ac1336542

> 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: Office of Inspections and Investigations
- Summary: Corza Medical Distribution GmbH, Austria Branch, a licensed combination product manufacturer in Linz, Austria, received an FDA Form 483 citing significant quality control and procedural deficiencies. Observations included the use of expired reagent standard curves for TachoSil product release and deficient investigations. The firm also failed to timely initiate deviations, close Out of Specification investigations, and adequately document sanitation practices in manufacturing areas.

## Related Documents

- [483 - 2025-09-12](https://www.keypedia.com/records/483/corza-medical-distribution-gmbh-austria-branch/d5971d89-6d04-40d4-9a8a-d28e1ba59b0a)

## Related Officers

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

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

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8