Drug firm Torrent Pharmaceuticals Friday said the US health regulator has made 'certain' observations after inspection of its Indrad facility in Gujarat. The audit at Indrad plant of the company was carried out by the United States Food and Drug Administration (USFDA) in April.
"We have received certain observations which are procedural in nature and the company is confident of addressing them satisfactorily," Torrent Pharmaceuticals said in a BSE filing.
The company, however, did not quantify how many observations were made by the US health regulator.
As per the USFDA, an "FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts".
It notifies the company's management of objectionable conditions.