For a better experience, Read this story in our App
-573.38
-169.60
+ 451.00
+ 1,908.00
+ 618.00
-573.38
-169.60
-169.60
+ 451.00
+ 451.00
+ 1,908.00
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.
Published on June 14, 2025
Comments
Comments have to be in English, and in full sentences. They cannot be abusive or personal. Please abide by our community guidelines for posting your comments.
We have migrated to a new commenting platform. If you are already a registered user of TheHindu Businessline and logged in, you may continue to engage with our articles. If you do not have an account please register and login to post comments. Users can access their older comments by logging into their accounts on Vuukle.