US FDA Identifies 11 Procedural Issues at Eugia Pharma's Telangana Facility

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US FDA Flags 11 Observations at Eugia Pharma's Telangana Unit

US FDA Flags 11 Observations at Eugia Pharma's Telangana Unit

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CNBC TV18•13-02-2026, 12:11

US FDA Flags 11 Observations at Eugia Pharma's Telangana Unit

•US FDA completed a CGMP inspection at Eugia Pharma Specialities Ltd's Unit-III in Telangana.
•The audit concluded with 11 observations under Form 483, indicating procedural and quality-system gaps.
•Observations relate to aseptic processing, environmental monitoring, QC oversight, and complaint handling.
•Eugia Pharma will submit a detailed response to the US FDA within the stipulated timeline.
•Aurobindo Pharma and Eugia Pharma face ongoing regulatory scrutiny, including past OAI classifications and warning letters.

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