
Shares of Aurobindo Pharma experienced a notable decline of over 5% following reports of observations made by the US Food and Drug Administration (FDA) regarding its Eugia Pharma Unit III.
According to CNBC reports, the FDA conducted an inspection of Aurobindo’s Eugia Pharma Unit III from January 22 to February 2, during which nine observations were issued.
These observations highlighted several deficiencies, including the lack of established procedures to prevent microbiological contamination of drugs purported to be sterile, incomplete data in laboratory records, and inadequate information in batch production and control records.
Additionally, the observations pointed out failures in thoroughly reviewing unexplained discrepancies and batch failures, as well as the absence of adequate written procedures for production and process controls.
The news of these observations led to a significant decline in Aurobindo Pharma shares, reaching a low of 958.50 around 9:45 am, almost falling by 5%.