FDA 483 - DDC Technologies, Inc. - September 06, 2024

DDC Technologies, Inc. in Oceanside, NY, a manufacturer of medical laser systems, was cited for five observations during an FDA inspection. The inspection revealed significant deficiencies in the firm's quality system, particularly concerning design controls, acceptance activities, CAPA, environmental controls, and complaint handling. These issues indicate a lack of adequate procedures and documentation to ensure product quality and regulatory compliance.