USFDA concludes inspection at Lupin’s Pithampur unit 3 manufacturing facility
The inspection closed with the issuance of a Form-483 with three observations
United States Food and Drug Administration (USFDA) has concluded inspection at Lupin’s Pithampur Unit-3 manufacturing facility. The inspection closed with the issuance of a Form-483 with three observations. The said inspection was conducted from July 07, 2025 to July 17, 2025.
The company will address the observations and collaborate with the USFDA to resolve them within the stipulated timeframe. The company 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.
