FDA 483 - DOT Gmbh - November 16, 2023

An FDA inspection of DOT GmbH, a manufacturer in Rostock, Germany, revealed significant deficiencies in the firm's quality system. The inspection found that procedures for receiving, reviewing, and evaluating complaints and nonconformances were not adequately established. Specifically, the firm failed to provide sufficient documentation and details within nonconformance reports regarding effectiveness monitoring and root cause investigations.