FDA 483 - Amoli Organics (A Division of Umedica Laboratories Pvt. Ltd.) - January 08, 2024

An FDA inspection of Amoli Organics (A Division of Umedica Laboratories Pvt. Ltd.), an Active Pharmaceutical Ingredients Manufacturer in Vadodara, India, identified a significant labeling deficiency. The firm was cited for shipping API products to the US market without including the required Caution Statement and Rx information on their labels. This indicates a failure to comply with specific legal labeling requirements for pharmaceutical ingredients.