Amoli Organics (A Division of Umedica Laboratories Pvt. Ltd.)January 8, 2024

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

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Record Details

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.

Company: Amoli Organics (A Division of Umedica Laboratories Pvt. Ltd.)
Inspection Date: January 8, 2024
Product Type: Drugs
Office: Office of Biological Products Operations - Division I
Person: Kham Phommachanh (Investigator)

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ID · a38281dd-dc32-49b6-bbc5-a5ed0ed10ea2