Sharon Bio-Medicine’s second plant inspected by FDA
Sharon Bio-Medicine’s second plant in Dehradun has been inspected recently by FDA post the earlier inspection at the company’s plant in Navi Mumbai
Drug firm Sharon Bio-Medicine’s two plants have been inspected by the US Food and Drug Administration (USFDA) following the recent plant inspection at Dehradun in Uthrakhand. The company confirmed the news to PTI that its formulation plant in Dehradun has been inspected following the earlier inspected at Navi Mumbai plant, within a span of 2 months.
Last month, USFDA had issued a warning letter to the firm for failing to pay generic drug user fee by its owner for three years starting 2013, saying its Dehradun-based facility would be barred from shipping products to the US if the dues are not cleared, as reported by PTI.
"In the last week one of our formulation plants at Dehradun in Uttarakhand has been inspected and audited by US Food and Drug Administration (USFDA) officials," Sharon Bio-Medicine said in a BSE filing.
USFDA had inspected company's manufacturing facility at Taloja near Navi Mumbai last month, it added.
"This is our second plant which has been inspected and audited by USFDA officials in the last two months. First plant at Taloja near Navi Mumbai was inspected and audited in the first week of July 2015," the company said.
Drug firm Sharon Bio-Medicine’s two plants have been inspected by the US Food and Drug Administration (USFDA) following the recent plant inspection at Dehradun in Uthrakhand. The company confirmed the news to PTI that its formulation plant in Dehradun has been inspected following the earlier inspected at Navi Mumbai plant, within a span of 2 months.
Last month, USFDA had issued a warning letter to the firm for failing to pay generic drug user fee by its owner for three years starting 2013, saying its Dehradun-based facility would be barred from shipping products to the US if the dues are not cleared, as reported by PTI.
"In the last week one of our formulation plants at Dehradun in Uttarakhand has been inspected and audited by US Food and Drug Administration (USFDA) officials," Sharon Bio-Medicine said in a BSE filing.
USFDA had inspected company's manufacturing facility at Taloja near Navi Mumbai last month, it added.
"This is our second plant which has been inspected and audited by USFDA officials in the last two months. First plant at Taloja near Navi Mumbai was inspected and audited in the first week of July 2015," the company said.
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