FDA 483 - Green Sprouts - August 16, 2023

Green Sprouts, a specification developer/repacker/relabeler in Asheville, NC, was cited with six observations during an FDA inspection. The observations primarily concern a lack of established procedures, documentation, and execution related to quality agreements, labeling control, quality audits, and management review of the quality system. This indicates significant deficiencies in the firm's quality management system.