A routine inspection by the United States Food and Drug Administration (US FDA) at Lannett Company LLC, a wholly owned step-down subsidiary of Aurobindo Pharma USA, Inc., has concluded with four observations.
The inspection was conducted at Lannett Company’s manufacturing facility in Seymour, Indiana, USA, from August 17 to August 21, 2026. According to the company’s regulatory filing, the inspection was carried out as part of the US FDA’s routine inspection process.
Aurobindo Pharma said the four observations identified during the inspection are procedural in nature. The company will submit its response 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 added that it will inform the stock exchanges about any further developments concerning the inspection, as required under applicable regulatory requirements.
The completion of the inspection marks the conclusion of the five-day US FDA inspection at the Seymour facility, with the company now expected to address the observations through its regulatory response.
