Business Standard

Lupin’s Goa plant receives adverse FDA observatio­ns

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Lupin stock fell 2.5 per cent on Thursday on media reports of the US Food and Drug Administra­tion (FDA) issuing adverse observatio­ns on its Goa plant. The plant remains crucial for Lupin as 50-60 per cent of supplies to the US are from this facility. The FDA issues observatio­ns known as Form 483 when it detects violations of good manufactur­ing practices. Lupin did not comment on the reports which said that company failed to review unexplaine­d discrepanc­ies and lack of procedures for production and process control. In the past, the unit was inspected in July 2015 and February 2016. The July 2015’s Form 483 was cleared in July 2016 and the latter in November 2016. The stock closed at ~ 1,337.25 on Thursday.

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