FDA 483 - Eckert & Ziegler Radiopharma GmbH - August 23, 2019

The FDA inspected Eckert & Ziegler Radiopharma GmbH, a manufacturer of radiopharmaceutical APIs, from August 19-23, 2019, resulting in multiple observations documented in an FDA Form 483. The findings highlight significant deviations from manufacturing quality standards. Main issues included inadequate environmental control and monitoring: smoke studies failed to demonstrate unidirectional airflow under dynamic conditions, and no studies were conducted for material transfer areas. Particle monitoring during transfers was insufficient, and disinfectant efficacy studies were absent. Critical HEPA filters lacked documented differential pressure, established limits, and in one case, a pressure gauge. Environmental and particle monitoring probes were improperly placed, yielding unreliable data. Furthermore, there were no written procedures for inspecting critical production component integrity. Quality control was cited for an insufficient investigation into foreign matter contamination, lacking a definitive root cause, particle characterization, or extended batch review. Data integrity was compromised by QC software without audit trail capabilities and review processes that overlooked electronic data and audit trails. Operators were observed not adhering to slow movement procedures in critical areas, without studies to assess the impact on airflow. The company is expected to provide comprehensive corrective and preventive actions to address these observations.