FDA 483 - Greenland Inc - July 11, 2024

An FDA inspection conducted from July 8-11, 2024, at Greenland Inc., a manufacturer located in Seattle, WA, revealed significant non-compliance with regulatory requirements. The inspection identified ten observations, primarily concerning the company's adherence to Good Manufacturing Practices for its Naturin2 dietary supplement products. Key violations included the absence of established identity, purity, strength, and composition specifications for both incoming components (such as various botanical roots and seeds) and finished products. The company also failed to conduct necessary testing on these materials upon receipt or at the finished product stage. Furthermore, Greenland Inc.'s quality control personnel did not properly approve or reject critical manufacturing controls, tests, or deviations, including the release of finished products and review of calibration records, a concern previously noted in a 2015 inspection. The inspection also found inadequate master and batch manufacturing records, lacking essential details such as in-process specifications, theoretical yields, equipment identification, and verification of component weights. Other issues included a lack of proper traceability for component lots, insufficient procedures for inspecting container closure defects, and the absence of a system to record and manage process deviations. These findings indicate a systemic failure to establish and follow robust quality control processes as required by the regulatory framework governing dietary supplement manufacturing. Greenland Inc. is required to promptly address these observations with comprehensive corrective actions to ensure product quality and regulatory compliance.