Dr Reddy’s Labs down after USFDA observations
Will address observations comprehensively within the stipulated timeline, DRL said.
By ETMarkets.com | Updated:
Agencies
Shares of Dr Reddy’s Laboratories closed lower in trade on Wednesday as the US health regulator issued 8 observations to the company after the inspection of its Duvvada facility in Andhra Pradesh.
The audit of the company’s formulations manufacturing plant (Vizag SEZ Plant 1) at Duvvada, Visakhapatnam by the United States Food and Drug Administration (USFDA) got completed on Tuesday, Dr Reddy's said in a filing to the BSE.
We have received a Form 483 with 8 observations. We will address them comprehensively within the stipulated timeline, the company said.
As per the US health regulator, “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 judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts."
The shares of the company closed 2.02 per cent lower at Rs 2503.40 on BSE.
The audit of the company’s formulations manufacturing plant (Vizag SEZ Plant 1) at Duvvada, Visakhapatnam by the United States Food and Drug Administration (USFDA) got completed on Tuesday, Dr Reddy's said in a filing to the BSE.
We have received a Form 483 with 8 observations. We will address them comprehensively within the stipulated timeline, the company said.
As per the US health regulator, “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 judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts."
The shares of the company closed 2.02 per cent lower at Rs 2503.40 on BSE.
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