FDA 483 - Mag & More Gmbh - June 21, 2023

An FDA inspection conducted at Mag & More Gmbh (Munich, Bavaria, Germany) from June 19 to June 21, 2023, identified four significant observations regarding the firm's quality system practices. The findings, documented in an FDA Form 483, indicate potential non-compliance with regulatory requirements for medical device manufacturers.

The primary issues observed included inadequacies in complaint handling procedures, where complaints were not consistently documented upon receipt, evaluated for Medical Device Reportability, or fully recorded during investigations. Furthermore, the design history file lacked complete documentation of design verification results, specifically regarding test results, design identification, and methods used. The firm's corrective and preventive action (CAPA) procedures were also found deficient, failing to adequately document the implementation and employee training for corrective actions or ensure proper information dissemination. Finally, purchasing control procedures lacked sufficiently defined requirements for evaluating supplier performance.

Mag & More Gmbh has committed to addressing these observations, with proposed completion dates for corrective actions ranging from August 31, 2023, to November 30, 2023. These actions are necessary to ensure adherence to established quality system regulations and uphold product safety and efficacy.