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

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.