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.