FDA 483 - Dr. Reddy's Laboratories Ltd. - July 29, 2026
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Dr. Reddy's Laboratories Ltd. was cited with three observations during an FDA inspection of its human prescription drug manufacturing facility in Ranasthalam Mandal, India. The inspection revealed deficiencies in laboratory controls for in-process materials, inadequate identity testing of incoming components, and a lack of systems to ensure compliance with DSCSA verification requirements. These issues indicate significant concerns regarding product quality, purity, and supply chain integrity for drugs distributed to the U.S. market.
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