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