# FDA 483 - Eckert & Ziegler Radiopharma GmbH - July 07, 2022

Source: https://www.globalkeysolutions.net/records/483/eckert-ziegler-radiopharma-gmbh/b438f3f5-b7d9-40b1-9119-dc1a916ef6e6

> FDA 483 for Eckert & Ziegler Radiopharma GmbH on July 07, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Eckert & Ziegler Radiopharma GmbH
- Inspection Date: 2022-07-07
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Eckert & Ziegler Radiopharma GmbH in Brunswick, Germany, a class III device contract manufacturer, revealed two significant observations. The firm was cited for using test equipment incapable of producing valid results due to a lack of qualification documentation. Additionally, the inspection found that essential equipment calibration, inspection, checks, and maintenance activities were not properly documented.

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Company: https://www.globalkeysolutions.net/companies/eckert-ziegler-radiopharma-gmbh/bfccc391-a5a7-425b-81e5-8f7eec703738

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd