# FDA 483 - Eckert & Ziegler Radiopharma GmbH - August 19, 2019

Source: https://www.globalkeysolutions.net/records/483/eckert-ziegler-radiopharma-gmbh/8349eeda-44e1-48d5-9b05-9fdab10fd2d8

> FDA 483 for Eckert & Ziegler Radiopharma GmbH on August 19, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Eckert & Ziegler Radiopharma GmbH
- Inspection Date: 2019-08-19
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Eckert & Ziegler Radiopharma GmbH, a manufacturer of radiopharmaceutical APIs in Berlin, Germany, was cited for significant deficiencies in environmental control, monitoring, and data integrity during an FDA inspection. Observations included inadequate smoke studies, lack of particle monitoring, unvalidated disinfectant efficacy, and issues with software audit trails and investigation practices. The findings indicate a need for improved aseptic processing controls and quality system oversight.

## Related Officers

- [Jose A. Cruz Gonzalez](https://www.globalkeysolutions.net/people/jose-a-cruz-gonzalez/a005cff1-0a90-4396-82c4-de4b0a579374)

Company: https://www.globalkeysolutions.net/companies/eckert-ziegler-radiopharma-gmbh/39c21864-c590-422c-a2be-9b308a4c8f0e

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