FDA 483 - Implantica CE Reflux Limited - October 24, 2025

Implantica CE Reflux Limited in San Gwann, Malta, received a Form 483 with four observations during an FDA inspection. The observations highlight significant deficiencies in the firm's quality system, including inadequate corrective and preventive action procedures, insufficient sampling method validation, an unstable organizational structure impacting quality operations, and poorly documented process validation activities. These issues indicate a need for comprehensive improvements across several critical quality system elements.