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Aurobindo Eugia and Kilo Pharma hit by FDA warning letters

Aurobindo Pharma logoAurobindo Pharma
Sig3.75Sen-5.75Env-2.85Soc-3.60Gov-4.70

FDA issued a warning letter to Aurobindo’s Eugia unit after a February Hyderabad inspection, flagging frequent manual interventions in aseptic areas and poor environmental monitoring. The agency also pointed to repeated manufacturing and aseptic practice violations across other facilities, after earlier Eugia issues including a 2024 Hyderabad Unit III letter and multiple Form 483s. Separately, an FDA warning letter targeted Kilo Pharmaceutical Sci-Tech in China for lacking evidence that its API process is reproducible and meets quality

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