FDA 483 - Premier Laboratory, LLC

Premier Laboratory, LLC, a contract testing facility in Longmont, CO, was inspected by the FDA from May 12-14, 2025. The inspection revealed significant deficiencies across multiple quality system areas, including inadequate management of deviations and CAPAs, insufficient quality oversight for product identity and purity, lack of proper GMP training, deficient supplier management, and unqualified or unmonitored equipment. These issues indicate a systemic breakdown in quality control and compliance with good manufacturing practices.