In its regulatory disclosure, the company stated that the US FDA concluded the inspection by issuing a Form 483 containing a total of nine observations. Aurobindo Pharma clarified that all the observations are procedural in nature and do not point to any critical or data-integrity related issues. The company added that it will submit a comprehensive response to the US regulator within the stipulated timelines.
The Unit-VII facility is situated at Polepally Village, Jedcherla Mandal, in Mahaboobnagar district of Telangana, and is engaged in the manufacture of oral solid dosage formulations. The inspection formed part of the US FDA’s routine oversight of overseas manufacturing sites supplying products to the US market.
Aurobindo Pharma emphasized that there has been no impact on its financial position, manufacturing operations, or other business activities as a result of the inspection and the observations issued. The company reiterated that its operations at the Jedcherla unit continue as normal.
The company further underlined its commitment to maintaining the highest quality and compliance standards across all its manufacturing facilities worldwide and stated that it regularly engages with global regulators to ensure adherence to applicable regulatory requirements.
Aurobindo Pharma said it remains focused on strengthening its quality systems and compliance framework while ensuring uninterrupted supply of medicines from its manufacturing facilities to global markets.
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