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USFDA pulls up Eugia for manufacturing lapses, data accuracy at Hyderabad plant

By Economic Times - 3 months ago
The US Food and Drug Administration (USFDA) has issued a warning letter to Eugia Pharma Specialities, a subsidiary of Aurobindo Pharma, citing significant manufacturing issues at its Telangana plant. The USFDA's inspection from January 22 to February 2, 2024, revealed problems including inaccurate production and process simulation data, falsified environmental monitoring records, and incomplete batch production and control records.

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