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

Source: https://www.keypedia.com/records/483/dr-reddys-laboratories-new-york-inc/dda2ab96-6bfe-4c8c-aea9-3851fb67d22c

> FDA 483 for Dr. Reddy's Laboratories New York, Inc. on May 16, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dr. Reddy's Laboratories New York, Inc.
- Inspection Date: 2025-05-16
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: 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.

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Company: https://www.keypedia.com/companies/dr-reddys-laboratories-new-york-inc/0eed3dcf-9a65-422d-95f0-c7fe0ec7debd

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961