# 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/ccede553-7554-4ad6-bac4-a3d83babc99c

> 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: New York District Office
- Summary: 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.

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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/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d