Sun Pharma faces US FDA scrutiny with eight observations after a plant inspection in Gujarat.

Sun Pharma, an Indian pharmaceutical company, has received eight observations from the US FDA following a recent inspection at its Halol plant in Gujarat. The inspection, focusing on good manufacturing practices, took place from June 2-13, 2025, and the FDA issued a Form 483, indicating possible violations of the Food, Drug, and Cosmetic Act. Sun Pharma has promised to address these issues promptly.