Sun Pharma gets 8 observations from USFDA for Halol plant

Drug major Sun Pharma on Saturday said the US health regulator has issued a Form 483 with 8 observations after inspecting its Halol (Gujarat) manufacturing plant.

The US Food and Drug Administration (USFDA) conducted a good manufacturing practices (GMP) inspection at the Halol facility from June 2-13 2025, the Mumbai-based drug maker said in a regulatory filing.

At the conclusion of the inspection, the USFDA issued a Form-483 with 8 observations, it added.

As per the USFDA, Form 483 is issued to a firm’s management at the conclusion of an inspection when the investigator has observed any conditions that may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.

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Published on June 14, 2025