Wockhardt gets warning letter from USFDA over Waluj plant
The company had earlier in May announced that the US Food and Drug Administration (USFDA) had issued an import alert on its Waluj facility, which makes injectables and solid dosages.
July 21, 2013 / 19:36 IST
Pharmaceutical firm Wockhardt said it has received a warning letter from US health regulator over its facility at Waluj in Maharashtra not meeting manufacturing norms.
The company had earlier in May announced that the US Food and Drug Administration (USFDA) had issued an import alert on its Waluj facility, which makes injectables and solid dosages. "The company have received a 'warning letter', which lists the observations made during the inspection," Wockhardt said in a filing to the BSE. Wockhardt said it has already initiated several corrective actions to resolve the same, adding it is maintaining the implications of the import alert on the company's consolidated revenues to be in the range of USD 100 million on an annualised basis. "Our earlier clarification on the implications of the import alert on the company's consolidated revenues for the current financial year remain unchanged. If any additional measures are necessary, the company would take them to squarely address all concerns," the filing added. The company continues to cooperate with USFDA to resolve the issues at the earliest, it said. Last week, UK Medicines and Healthcare Products Regulatory Agency (MHRA) had issued a precautionary recall for sixteen medicines made by Wockhardt at its Waluj unit on manufacturing shortcomings, after imposing an import alert on the export-oriented unit earlier.
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