# FDA 483 - Thymoorgan Pharmazie Gmbh - April 25, 2023

Source: https://www.keypedia.com/records/483/thymoorgan-pharmazie-gmbh/b7e78cf9-d88b-4614-9d5c-431a98b581ca

> FDA 483 for Thymoorgan Pharmazie Gmbh on April 25, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Thymoorgan Pharmazie Gmbh
- Inspection Date: 2023-04-25
- Product Type: drugs
- Office Name: Baltimore District Office
- Summary: This summary details observations made by the U.S. Food and Drug Administration (FDA) during an inspection of Thymoorgan Pharmazie GmbH, a sterile drug manufacturer located in Germany. Conducted from April 17 to April 25, 2023, the inspection resulted in a Form FDA 483, outlining significant deviations from good manufacturing practices.

Key violations centered on inadequate investigations into unexplained discrepancies. This included a substantial leak in a HEPA filter within an aseptic processing system, which lacked documented scientific rationale for asserting no product impact. Furthermore, environmental monitoring revealed pathogens such as E. coli and B. cereus/thuringiensis/mycoides in various locations, including Grade D areas, which were not thoroughly investigated due to limitations in the firm's standard operating procedures that only mandated investigations for higher-grade zones.

The inspection also identified deficiencies in the environmental monitoring systems for aseptic processing. Specifically, non-viable particle monitoring sensors were absent in several critical zones within the restricted access barrier system on Line X, used for manufacturing sterile drug products like injection vials. Finally, operators failed to consistently follow written production and process control procedures; an operator was observed performing multiple interventions during aseptic filling operations without recording these actions in the batch record at the time of occurrence, contrary to established company protocols. Thymoorgan Pharmazie GmbH is expected to implement robust corrective and preventive actions to address these findings and ensure compliance with regulatory standards for sterile drug production.

## Related Documents

- [483 - 2023-04-25](https://www.keypedia.com/records/483/thymoorgan-pharmazie-gmbh/91dc3480-59c7-4907-a84a-4c3bfc75a1ae)

## Related Officers

- [Drug Discovery and Biotech Executive](https://www.keypedia.com/people/lloyd-d-payne/8b98c38a-4fbe-465d-bb0a-689bcc6db702)

Company: https://www.keypedia.com/companies/thymoorgan-pharmazie-gmbh/b58b84eb-57d4-4730-8fbb-58632f71023d

Office: https://www.keypedia.com/offices/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa