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

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.