USFDA issues Form-483 with 4 observations to Lupin's Pithampur Unit-2 facility

The company is working with the USFDA to satisfactorily resolve the compliance issues and is committed to being compliant with CGMP (current good manufacturing practice) standards at all its manufacturing facilities, it added.

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26 Aug, 2025 12:21

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Drug firm Lupin on Saturday said the US health regulator has issued a Form-483 with four observations after inspecting its Pithampur Unit-2 manufacturing facility.

The US Food and Drug Administration (USFDA) inspected the facility from July 8 to 17, 2025, and closed with the issuance of a Form-483 with four observations, the Mumbai-based drug maker said in a regulatory filing. ”We would like to update that U.S. FDA has determined the inspection classification of this facility as ’Official Action Indicated (OAI)’,” the drug maker said.

The company is working with the USFDA to satisfactorily resolve the compliance issues and is committed to being compliant with CGMP (current good manufacturing practice) standards at all its manufacturing facilities, it added. Form 483 is issued to a firm’s management at the conclusion of an inspection when the investigator has observed any conditions that may constitute violations of the Food, Drug and Cosmetic (FD&C) Act and related Acts, as per the USFDA.