FDA 483 - Premier Laboratory, LLC

Premier Laboratory, LLC, a contract testing facility in Longmont, CO, was cited for significant deficiencies during an FDA inspection. The observations primarily concern inadequate quality system controls, including poor management of deviations, OOS, and CAPAs, insufficient quality oversight for product identity and purity, and a lack of proper employee training. Additionally, the firm failed to adequately manage suppliers and ensure equipment qualification and monitoring.