Lupin tanks to 3-year lows on USFDA observations

There are no appropriate control procedures established over computers or related systems,USFDA observed.

Lupin tanks to 3-year lows on USFDA observations
NEW DELHI: Shares of Lupin tanked to a 3-year low on Thursday amid reports that the company's drug facility at Pithampur, Madhya Pradesh, has received five observations from US Food and Drug Administration (USFDA).

Following the development, the scrip dropped 2.49 per cent to close at Rs 1,066.95, its lowest level since July 2014.

According to media reports, USFDA told the pharma company "There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed".

There are no appropriate control procedures established over computers or related systems, the report quoted USFDA observation as saying.

USFDA said that the samples of in-process materials at the company's Pithampur unit 3 were not representative.

USFDA told the company that the acceptance criteria for the sampling conducted during June 12 to June 16, 2017 was inadequate, the report said.
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