The 'Import Alert' implies that all future shipments of products manufactured at this facility are subject to refusal of admission to the US market until the facility becomes compliant with CGMP (Current Good Manufacturing Practice) standards.
The USFDA has excluded 14 products from the restriction, the company said.
"For the year ended March 31, 2022, supplies to the US market from the Halol facility accounted for approximately 3% of the company’s consolidated revenues, including the 14 excluded products," it said, adding that the company will undertake all necessary steps to resolve these issues and to ensure that the regulator is completely satisfied with the remedial action.
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