FDA 483 - Genesis Alkali LLC - July 15, 2021

Genesis Alkali Wyoming, LP, an active drug substance manufacturer in Green River, WY, was cited for four observations during an FDA inspection. The firm lacked procedures for testing recovered materials, had inadequate controls over computerized laboratory systems, performed insufficient Out-of-Specification investigations, and maintained inaccurate and incomplete written records. These issues indicate significant deficiencies in quality control and data integrity.