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

Source: https://www.globalkeysolutions.net/records/483/thymoorgan-pharmazie-gmbh/91dc3480-59c7-4907-a84a-4c3bfc75a1ae

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

---

## Details

- Record Type: 483
- Company Name: Thymoorgan Pharmazie Gmbh
- Inspection Date: 2023-04-25
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Thymoorgan Pharmazie Gmbh, a sterile drug manufacturer in Goslar, Germany, received a Form 483 with three observations. The inspection revealed significant deficiencies in discrepancy investigations, environmental monitoring for aseptic processing, and adherence to and documentation of production procedures. These issues indicate a lack of control over critical manufacturing processes for sterile drug products.

## Related Officers

- [Wayne D. Mcgrath](https://www.globalkeysolutions.net/people/wayne-d-mcgrath/42db5ab0-2e0b-4909-951c-e7621cd04f6e)

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

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1