USFDA concludes inspection at Lupin’s Pithampur Unit-2 manufacturing facility
The inspection closed with the issuance of a Form-483 with four observations
United States Food and Drug Administration (USFDA) has concluded inspection at Lupin’s Pithampur Unit-2 manufacturing facility. The inspection closed with the issuance of a Form-483 with four observations. The said inspection was conducted from July 08, 2025 to July 17, 2025.
The company is addressing these observations comprehensively and will respond to the USFDA within the stipulated timeframe. It upholds quality and compliance with utmost importance and is committed to be compliant with CGMP quality standards across all its facilities.
Lupin is an innovation led transnational pharmaceutical company producing, developing and marketing a wide range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) globally.
