FDA 483 - Imagilin Technology Llc - January 16, 2020

An FDA inspection of Imagilin Technology LLC, a manufacturer of dietary supplements, identified significant deficiencies in their manufacturing processes. The firm failed to establish and follow written master manufacturing records for their probiotic products. Additionally, Imagilin Technology LLC did not establish required product specifications for identity, purity, strength, composition, or contamination limits for their finished dietary supplements and their components.