483
Eckert & Ziegler Radiopharma GmbHEckert & Ziegler Radiopharma GmbH – FDA 483, Jul 7, 2022
Record Details
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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ID · b438f3f5-b7d9-40b1-9119-dc1a916ef6e6
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