FDA 483 - Future Diagnostics Solutions B.V. - January 19, 2023

Future Diagnostics Solutions B.V. in Wijchen, Netherlands, was cited with four observations during an FDA inspection. The firm failed to submit Medical Device Reports (MDRs) for device malfunctions and lacked statistically valid sampling plans. Additionally, procedures for quality audits and corrective and preventive actions were not adequately established, indicating significant quality system deficiencies.