Torrent Pharmaceuticals on Friday said the US health regulator has issued Form 483 with one observation after inspecting its Gujarat-based manufacturing facility.
The US Food and Drug Administration (USFDA) conducted the pre-approval inspection of the Bileshwarpura-based plant from March 13-17.
"At the end of the inspection, we have been issued a 'Form 483' with 1 observation, which is procedural in nature. We will respond to the USFDA within the stipulated timeline and work closely with USFDA to address the observation at the earliest," the drug maker said in a regulatory filing.
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.