USFDA issues 4 observations for Torrent Pharma’s Indrad plant

Torrent Pharma says its has discussed action plan during audit process and a detailed response will be submitted within the stipulated time to FDA


Torrent Pharma said none of USFDA’s observations is concerning product quality or data reliability.
Torrent Pharma said none of USFDA’s observations is concerning product quality or data reliability.

New Delhi: Drug firm Torrent Pharmaceuticals, or Torrent Pharma, on Friday said the US health regulator has issued four observations after inspection of its Indrad facility in Gujarat.

The United States Food and Drug Administration (USFDA) inspectors have carried the audit of the Indrad plant.

Four observations have been received from them relating to improvement in procedures and in documentation processes, Torrent Pharma said in a BSE filing.

“None of the observations is concerning product quality or data reliability”, it added.

The company has discussed the action plan during the audit process and a detailed response will be submitted within the stipulated time to FDA, Torrent Pharma said.

As per 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.

Shares of Torrent Pharmaceuticals closed 1.53% lower at Rs1,298.55 per scrip on BSE.

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