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

Dr. Reddy's Laboratories New York LLC in Middleburgh, NY, an API manufacturer, was cited for two significant issues during an FDA inspection. Observations included inadequate cold storage conditions for API products and materials, where visible black mold was found on containers and metal totes. Additionally, the firm's quality unit failed to perform an annual product quality review for its Conjugated Estrogens USP product.