FDA 483 - Imagilin Technology Llc - November 09, 2023

Imagilin Technology Llc in Frederick, MD, a manufacturer of dietary supplements, was inspected by the FDA. The inspection revealed significant deficiencies in quality control, including a lack of established specifications for components and finished products, inadequate testing of dietary ingredients, and incomplete batch production records. Additionally, the firm failed to establish written quality control procedures and ensure proper calibration of instruments.