Drug firm Lupin on Saturday said the US health regulator has issued six observations after the inspection of a unit of its Pithampur facility in Madhya Pradesh.
The inspection of Pithampur Unit -2 was carried out by the United States Food and Drug administration (USFDA) between January 14 and January 25, 2019, Lupin said in a statement.
“The inspection at Pithampur Unit-2 (Indore) closed with 6 observations,” it added.
The company, however, did not provide any details about the nature of the observations.
The company is confident of addressing the observations satisfactorily, Lupin said.
The US health regulator issues observations by means of a FDA Form 483 notifying the company’s management of objectionable conditions at the facility inspected.
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.