USFDA inspection: Lupin gets 10 observations for Pithampur facility

Mumbai: Lupin has recently announced that US Food and Drug Administration (U.S. FDA) has concluded an inspection with ten observations at the company's Pithampur Unit-2 manufacturing facility.

The inspection was conducted from March 21 to March 29, 2023.

"The inspection closed with issuance of a Form-483 with ten observations. We are addressing the observations comprehensively and will work with the U.S. FDA to resolve these issues at the earliest. We uphold quality and compliance with utmost importance across all our facilities," the company stated in a BSE filing.

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

Medical Dialogues team had earlier reported that Lupin Limited had successfully completed the inspection carried out by the UK Medicines and Healthcare products Regulatory Agency (UK MHRA) at its Pithampur facilities in India.

Read also: Lupin successfully completes UK MHRA inspection at Pithampur facilities

Lupin is a transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.

The Company specializes in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastrointestinal (GI), central nervous system (CNS), and women’s health areas. The company invested 8.7% of its revenue in research and development in FY22.

Read also: Lupin pharmacovigilance group concludes USFDA inspection with no observations