05 Oct 2025 | 3 Mins Read
USFDA issues Form-483 with 4 observations to Lupin Pithampur Unit
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Drug major Lupin's Pithampur Unit-2 facility was inspected by the US FDA from July 8-17, 2025. A Form-483 with four observations was issued. The USFDA classified the inspection as 'Official Action Indicated (OAI)'. Lupin is working with the FDA to resolve compliance issues and ensure CGMP standards are met.