FDA 483 - Rapid Biomedical GmbH - July 05, 2018

Raumedical GmbH, a medical device manufacturer in Rimpar, Germany, was cited for significant quality system deficiencies during an FDA inspection. The firm's medical device reporting procedures were found to be inadequate, and software used in production and the quality system was not validated. Additionally, sampling plans lacked statistical rationale, and corrective and preventive action procedures were not adequately established.