FDA 483 - Greenland Inc - July 11, 2024

Greenland Inc. in Seattle, WA, was inspected by the FDA from July 8-11, 2024, and received a Form 483 with 10 observations. The inspection revealed significant deficiencies in the firm's manufacturing processes for dietary supplements, particularly concerning the establishment and verification of specifications for components, in-process materials, and finished products. Repeat observations from a 2015 inspection indicate persistent issues with quality control and batch record completeness.