FDA 483 - Elementis SRL, Inc. - May 24, 2024

Elementis SRL Inc., an API manufacturer in Huguenot, NY, received a Form 483 with nine observations during an FDA inspection from May 20-24, 2024. The observations highlight significant deficiencies across manufacturing process validation, data integrity, quality control, equipment calibration and cleaning, stability studies, and water system management. These issues indicate a broad lack of adequate controls and adherence to established procedures for API production.