New Delhi - Torrent Pharmaceuticals said on Friday that the US health regulator issued Form 483 with a remark after inspecting its Gujarat-based manufacturing facility. The United States Food and Drug Administration (USFDA) carried out the pre-approval inspection of the Bileshwarpura-based plant from March 13-17.
"At the end of the inspection, we were issued a 'Form 483' with 1 comment, which is procedural in nature. We will respond to USFDA within the stipulated time frame and will work closely with USFDA to address the comment as soon as possible." the drugmaker said in a regulatory filing.
According to the USFDA, Form 483 is issued to a company's management at the end of an inspection, when the investigator has observed any conditions that may constitute a violation of the Food, Drug, and Cosmetic (FD&C) Act and related laws.
