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USFDA issues warning letter for Wockhardts Waluj plant

By: Pharma News | Views: 1131 | Date: 08-Aug-2013

Last week, the UK Medicines and Healthcare Products Regulatory Agency (MHRA) had issued a precautionary recall for sixteen medicines manufactured by Wockhardt at its Waluj facility due to manufacturing inadequacies and prior to that had imposed an import alert on the export-oriented unit.

USFDA issues warning letter for Wockhardts Waluj plant



USFDA Warning

Last week, the UK Medicines and Healthcare Products Regulatory Agency (MHRA) had issued a precautionary recall for sixteen medicines manufactured by Wockhardt at its Waluj facility due to manufacturing inadequacies and prior to that had imposed an import alert on the export-oriented unit.

Now, the firm Wockhardt Ltd is reported to have received a warning letter from the USFDA over its facility at Waluj in Maharashtra, as having shortcomings in standard manufacturing norms. Two months ago, USFDA had issued an import alert on its Waluj facility, which makes injectables and solid dosages.

As reported by the company, it received a 'warning letter', containing observations made during the inspection. The company says several corrective actions to resolve the same have already been initiated. Also, that it is maintaining the import alert on the company's consolidated revenues to be in the range of USD 100 million on an annualised basis. The company aims at co-operating with USFDA to resolve the issues at the earliest.

According to FDA, the firm repeatedly delayed, denied, limited an inspection or refused to permit the FDA inspection. FDA recently presented a guidance document, in which it expanded the definition of what constitutes a delay, denial, limit or refusal of an inspection.
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