Drug-maker Wockhardt has received a warning letter from the regulatory United States Food and Drug Administration, listing observations made during its inspection of the company’s Waluj facility. The company has initiated corrective actions to resolve the issues, Wockhardt said, in a statement to the BSE. The company’s stock had dipped over six percent, closing at Rs 889 on the BSE, on Friday. Earlier in May, Wockhardt had said that it had received an import alert from the USFDA. An “import alert" involves the detention without physical examination of drugs from firms that have not met the mandated good manufacturing practices. Wockhardt Chairman Habil Khorakiwala had then also estimated that the company would take a Rs 550-crore hit on its annual revenue. In its latest disclosure to the stock exchange, the company said, that its earlier financial projection on the impact of the import alert remained unchanged. If any additional measures are necessary, the company would undertake them, Wockhardt said, adding that it was co-operating with the FDA.
UK troubles: In fact, only last week, the regulator in the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) had issued a precautionary recall for sixteen medicines made by Wockhardt at its Waluj plant. This followed “manufacturing deficiencies”, the MHRA had said. Wockhardt had then responded that the total one-time impact of the UK MHRA recall would be about Rs 13.5 crore.