USFDA issues 4 observations for Torrent Pharmaceuticals Indrad plant
New Delhi: Drug firm Torrent Pharmaceuticals 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 Pharmaceuticals 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 Pharmaceuticals said.
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 companys management of objectionable conditions.
Shares of Torrent Pharmaceuticals closed 1.53 per cent lower at Rs 1,298.55 per scrip on BSE.
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 Pharmaceuticals 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 Pharmaceuticals said.
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 companys management of objectionable conditions.
Shares of Torrent Pharmaceuticals closed 1.53 per cent lower at Rs 1,298.55 per scrip on BSE.
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