Sun Pharma gets eight observations from USFDA for Halol plant

Sun Pharma announced that the USFDA issued a Form 483 with eight observations after inspecting its Halol manufacturing plant in Gujarat. The USFDA conducted a Good Manufacturing Practices (GMP) inspection at the facility from June 2-13, 2025. The Form 483, issued at the inspection's conclusion, highlights conditions that may violate the Food, Drug, and Cosmetic Act and related regulations.

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