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

During an FDA inspection conducted from July 4-7, 2022, Eckert & Ziegler Radiopharma GmbH, a Class III device contract manufacturer based in Brunswick, Germany, received a Form FDA-483. The inspection highlighted critical deficiencies concerning equipment used in the manufacturing of their OncoSil system. The primary observation indicated that certain test equipment was not capable of producing valid results. Specifically, two pieces of equipment essential for manufacturing steps lacked proper identification within the firm's system, and there was no documentation of their installation, operation, or performance qualifications, raising concerns about their suitability. The second major observation noted that critical equipment calibrations, inspections, and maintenance activities for these same pieces of equipment had not been documented. This absence of records means the accuracy and reliability of equipment continuously used since 2005 could not be assured. These observations signify a need for the company to address its quality system deficiencies regarding equipment control and record-keeping, as per the Federal Food, Drug, and Cosmetic Act. Eckert & Ziegler Radiopharma GmbH is expected to review these findings, implement comprehensive corrective actions, and may submit a response to the FDA detailing their plans for remediation.