New Delhi, Apr 28 (PTI) Drug firm Lupin today said the US health regulator FDA has issued three observations after inspecting its Goa plant.
“Recently the company’s manufacturing facility underwent an inspection by the USFDA…subsequently to that USFDA issued Form 483 citing three observations,” Lupin Ltd said in a regulatory filing.
The company is in the midst of putting together a response to address the said observations, it added.
As per the USFDA, observations are made in Form 483 when investigators feel that conditions or practices in the facility are such that products may become adulterated or render injuries to health.
The FDA Form 483 notifies the company’s management of objectionable conditions.
This is published unedited from the PTI feed.