Aurobindo's Lannett Facility Gets USFDA OAI Classification After 4 Observations
Hyderabad: Aurobindo Pharma Limited has announced that the US Food and Drug Administration (USFDA) has classified the inspection of its wholly owned step-down subsidiary, Lannett Company LLC, as Official Action Indicated (OAI) following an inspection of its manufacturing facility in Seymour, Indiana, USA.
According to the company’s regulatory filing, the US FDA conducted an inspection at the Lannett Company facility from August 17 to 21, 2026. Following the inspection, the regulatory authority issued four observations to the facility.
Aurobindo Pharma stated that it had submitted responses to all four observations within the stipulated timeframe. However, the US FDA has now determined the inspection classification of the facility as OAI.
The OAI classification indicates that the FDA has identified issues requiring regulatory action or follow-up. The company has stated that it remains committed to maintaining robust quality and compliance standards across its manufacturing facilities.
In its filing, Aurobindo Pharma clarified that the regulatory action will have no impact on the company’s financials or operations.
The company further stated that it will keep the stock exchanges informed of any additional developments in the matter, in accordance with applicable regulatory requirements.
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