Aurobindo Pharma Gets 4 USFDA Observations for Lannett Facility
Hyderabad: The United States Food and Drug Administration (USFDA) has concluded a routine inspection at Lannett Company LLC, a wholly owned step-down subsidiary of Aurobindo Pharma, with four procedural observations.
The inspection was conducted at Lannett's facility in Seymour, Indiana, USA, from August 17 to August 21, 2026.
Aurobindo Pharma disclosed the development pursuant to Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015, stating that the company will submit its response to the US FDA within the stipulated timeline.
According to the company's communication, the US FDA conducted the routine inspection at Lannett Company LLC, identified as a wholly owned step-down subsidiary of Aurobindo Pharma, during the five-day period.
Upon completion of the inspection, the facility received four observations. Aurobindo Pharma stated that the observations are procedural in nature and that it will respond to the US FDA within the stipulated timeline.
The company further stated that it remains committed to maintaining robust quality and compliance standards across its manufacturing facilities.
Aurobindo Pharma has therefore formally informed the stock exchanges that the routine US FDA inspection at its step-down subsidiary Lannett Company LLC's Seymour, Indiana facility has concluded with four procedural observations. The company has undertaken to submit its response to the US FDA within the stipulated timeline and continue maintaining quality and compliance standards across its manufacturing facilities.
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