FDA 483 - Purisys LLC - March 13, 2024

An FDA inspection of Purisys LLC, an API and intermediate manufacturer in Athens, GA, revealed significant unsanitary conditions and pest control issues throughout the facility. Inspectors observed microbiological discoloration, flies, bird droppings, spiders, and a roach in various production and storage areas. Additionally, the firm lacked adequate written procedures for the handling and cleaning of raw material containers, particularly those exposed to the environment.