FDA 483 - Merete GmbH - August 29, 2018

Merete Medical GmbH, a specification developer in Berlin, Germany, was cited for significant deficiencies in its quality system during an FDA inspection. The firm failed to timely report medical device adverse events, lacked established procedures for corrective and preventive actions, and exhibited multiple issues with design control, including validation, verification, and input documentation for its BioBall hip systems. Additionally, complaint handling procedures and written MDR procedures were found to be inadequate.