FDA 483 - Psoria Shield, Inc. - September 14, 2023

Psoria Shield, Inc. in Utica, NY, was inspected by the FDA, revealing significant deficiencies in its quality system. The inspection found issues across multiple areas, including equipment calibration, vendor management, complaint handling, and corrective and preventive actions. These observations indicate a lack of established and adequately implemented procedures crucial for ensuring product quality and regulatory compliance.