FDA 483 - MEDICREATIONS LLC - March 20, 2025

MEDICREATIONS LLC, a manufacturer of Class I and Class II medical devices in Las Vegas, NV, was cited for 11 observations during an FDA inspection. The findings indicate significant deficiencies across its quality system, including inadequate procedures for design transfer, UDI labeling and registration, device history records, supplier management, incoming product acceptance, equipment calibration, CAPA, complaint handling, servicing activities, and product handling. These issues suggest a broad lack of control over critical manufacturing and quality processes.