FDA 483 - OMT, LLC - March 05, 2025

OMT, LLC in Fort Lauderdale, FL, a specification developer, was inspected by the FDA from February 26 to March 5, 2025. The inspection revealed significant and repeat deficiencies across its quality management system, including inadequate design validation for shelf life, ineffective corrective and preventive actions, and failures in supplier evaluation, acceptance activities, environmental control, quality audits, management review, and personnel training. These issues indicate a systemic lack of adherence to established procedures and regulatory requirements, with many observations being repeat deficiencies from previous inspections.