USFDA Warning Letter resolved: Lupin, Goa, Pithampur

The satisfactory evaluation of the corrective actions implemented by Lupin has led to the resolution of the regulatory concerns.

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Last Updated on December 30, 2023 by The Health Master

USFDA Warning Letter

Lupin, a leading pharmaceutical company, has successfully addressed the concerns raised in the U.S. Food and Drugs Administration (USFDA) warning letter for its manufacturing facilities in Goa and Pithampur Unit-2, Indore.

The USFDA’s approval comes after thoroughly evaluating the corrective actions taken by Lupin in response to the warning letter issued on November 6, 2017.

Resolving USFDA Warning Letter:

Lupin received a correspondence from the USFDA, confirming that the company has effectively addressed the issues mentioned in the warning letter for its Goa and Pithampur Unit-2 facilities.

The satisfactory evaluation of the corrective actions implemented by Lupin has led to the resolution of the regulatory concerns.

Commitment to Compliance and Quality:

Nilesh Gupta, the Managing Director of Lupin, expressed his satisfaction with the USFDA’s acknowledgment.

He stated, “We are pleased to be informed by the USFDA that we have addressed the concerns through our corrective actions related to the November 2017 Warning Letter.

“We are committed to being compliant with good manufacturing practices, and to uphold global quality standards and ensuring the quality of our products.”

Background:

In November 2017, Lupin received a warning letter from the USFDA highlighting specific issues found during inspections of its manufacturing facilities in Goa and Pithampur Unit-2, Indore.

The warning letter indicated the need for corrective actions to address the identified concerns and ensure compliance with the FDA’s regulations and guidelines.

Significance of Resolving the Warning Letter:

The resolution of the USFDA warning letter is of paramount importance for Lupin and its stakeholders.

It signifies that the company has successfully rectified the compliance issues and taken appropriate measures to ensure the quality, safety, and efficacy of its products.

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