FDA 483 - Elementis SRL, Inc. - March 17, 2022

Elementis SRL, INC, an Active Pharmaceutical Ingredient manufacturer in Middletown, New York, received two observations during an FDA inspection. The firm's Quality Unit failed to conduct annual product reviews for API batches. Additionally, the quality unit did not fully investigate or resolve out-of-specification (OOS) results, attributing all root causes to operator error without implementing corrective or preventative actions.