FDA 483 - Amoli Organics (A Division of Umedica Laboratories Pvt. Ltd.) - January 12, 2024

During an inspection conducted from January 8-12, 2024, by the United States Food and Drug Administration, Amoli Organics (A Division of Umedica Laboratories Pvt. Ltd.), an Active Pharmaceutical Ingredients manufacturer located in Vadodara, Gujarat, India, received an FDA Form 483. This document outlines observations made by the FDA representatives regarding potential deviations from regulatory requirements. The primary observation noted was the failure to include special legal requirements, specifically the "Caution Statement" and "Rx" symbol, on the labels of active pharmaceutical ingredients (APIs) shipped to the U.S. market. For instance, specific lots of (b) (4) USP (b) (4) API shipped in 2021 and 2023 were found to be missing these critical statements. This observation indicates a non-compliance with U.S. labeling regulations for pharmaceutical ingredients, which are essential for ensuring proper handling and dispensing within the supply chain. While the FDA Form 483 itself does not represent a final agency determination, it requires a formal response from Amoli Organics. The company is expected to discuss any objections, or propose and implement corrective actions to address the identified labeling deficiencies to ensure future shipments of APIs to the U.S. market comply fully with all mandated regulatory labeling requirements.