Aurobindo Pharma: US FDA Inspection at Subsidiary Concludes with 4 Observations

Aurobindo Pharma Limited has announced the conclusion of a routine US FDA inspection at its wholly owned subsidiary, Lannett Company LLC. The inspection, held from August 17th to August 21st, 2026, resulted in four observations. The company stated these observations are procedural in nature and that it will provide a response within the stipulated timeline, reaffirming its commitment to quality and compliance.

US FDA Inspection at Lannett Company LLC

Aurobindo Pharma Limited has informed stakeholders about the completion of a routine inspection conducted by the United States Food and Drug Administration (US FDA) at its subsidiary, Lannett Company LLC. The inspection took place at the subsidiary’s facility located in Seymour, IN, USA, from August 17th to August 21st, 2026.

Inspection Findings and Response

The inspection concluded with a total of four observations. Aurobindo Pharma has clarified that these observations are primarily procedural in nature. The company has committed to submitting its formal response to the US FDA within the designated timeline. This proactive approach underscores Aurobindo Pharma’s dedication to upholding robust quality and compliance standards across all its manufacturing operations.

Commitment to Quality

Aurobindo Pharma reiterated its ongoing commitment to maintaining the highest standards of quality and compliance across its global manufacturing facilities. The company will continue to provide updates to the stock exchanges as required by applicable regulations.

Source: BSE

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