Dr. Reddy's Laboratories New York, Inc.May 16, 2025

FDA 483 - Dr. Reddy's Laboratories New York, Inc. - May 16, 2025

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Record Details

An FDA inspection of Dr. Reddy's Laboratories New York LLC in Middleburgh, NY, an API manufacturer, revealed two significant observations. The firm failed to maintain adequate cold storage conditions for API products and materials, with visible mold observed on containers. Additionally, the quality unit did not complete the required annual product quality review for Conjugated Estrogens USP batches manufactured in 2024.

Company: Dr. Reddy's Laboratories New York, Inc.
Inspection Date: May 16, 2025
Product Type: Drugs
Office: Division of Human and Animal Food Operations - East I
People: Vivin George
Raihan A. Chowdhury
Paige R. McCoy

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ID · dda2ab96-6bfe-4c8c-aea9-3851fb67d22c