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As the US intensifies its scrutiny of drug companies, Sun Pharma said it too had faced minor queries from that nation’s Food and Drug Administration (FDA).
“These were minor observations, and the company responded to these a long time back,” Sun said of the USFDA’s queries on its Caraco plant in the US. The development comes even as the Caraco plant is emerging from its earlier tryst with USFDA.
483 observation
In the latest development, a Bloomberg report, citing information got through the Freedom of Information Act request (similar to India’s RTI), said Sun’s US subsidiary, Caraco, had two ‘483’ observations on its plant, following inspections in January and May this year. In a 483 observation, the FDA’s concerns are first raised with the company management.
The issue is put to rest if the company is able to satisfy the queries. Failing this, the issue could escalate into a more serious warning letter.
Angel Broking’s Sarabjit Kour Nangra said the development is good in that the company had done its part by addressing the USFDA’s queries. The concerns do not seem to be major, she added.
Bloomberg had said the concerns raised by the FDA included temperature control lapses, improperly sealed containers and deviation of quality control procedures.
Drug-makers Ranbaxy and Wockhardt have come in for the stick from the USFDA over quality issues involving manufacturing facilities in India.
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