FDA 483 - Maquet Cardiopulmonary GmbH - June 24, 2022

An FDA inspection of Maquet Cardiopulmonary GmbH in Hechingen, Germany, revealed significant deficiencies across multiple quality system areas. The firm failed to adequately establish and implement procedures for corrective and preventive actions, design validation, risk analysis, design review, and process validation. These issues are particularly severe as the firm was previously issued a 483 in 2013 for similar deficiencies, leading to a Consent Decree in 2015.