On Wednesday Lupin, the Indian pharmaceutical major based in Mumbai stated in an exchange filing that USFDA inspected its Nagpur Oral Solid Dosage Facility from July 3 to July 11, 2023

On Wednesday Lupin, the Indian pharmaceutical major based in Mumbai stated in an exchange filing that USFDA inspected its Nagpur Oral Solid Dosage Facility from July 3 to July 11, 2023. The company further revealed that the USFDA has closed the inspection with the issuance of form 483 with two observations. 

According to the FDA, an FDA Form 483 is issued to a firm’s management at the conclusion of an inspection when an investigator has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. 

“We would like to inform you that U.S. FDA inspected Lupin’s Nagpur Oral Solid Dosage Facility from July 3 to July 11, 2023. The inspection closed with issuance of a Form-483 with two observations,” the company said in the exchange filing. 

Lupin said that it is confident of addressing the observations raised, and will work with the U.S. FDA to resolve them at the earliest. 

“We uphold quality and compliance issues with utmost importance and remain committed to being compliant with CGMP quality standards across all our facilities, the company stated. 

The company’s stock was trading 1.33 percent lower on Thursday at Rs 927.75 per scrip on BSE as of 11:29 IST.

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