483
Dr. Reddy's Laboratories New York, Inc.FDA 483 - Dr. Reddy's Laboratories New York, Inc. - May 16, 2025
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
Record Details
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.
Open in Dashboard
ID · ccede553-7554-4ad6-bac4-a3d83babc99c