Wockhardt Plant in India Gets FDA Warning Letter
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July 22nd, 2013 // 12:34 pm @ jmpickett
Wockhart Ltd stated this week that it had received a warning letter from FDA for its plant in Waluj, Maharashtra, India. The plant did not meet several aspects of the GMP regulations.
The company also reported in May that FDA had put out an import alert on the Waluj plant, which is the manufacturer of both injectables and solid dosages.
Wockhardt stated that it had made a number of corrective changes to resolve the CGMP violations. It also noted that it is maintaining operations with the import alert in place, and it expects revenues to be in the range of $100 million in 2013.
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The stock shares for Wockhardt dropped 10% in morning trading after news of the warning letter hit the wires.
Wockhardt stated that the impact of the import alert on the firm's revenues are to be expected, but that the import alert will be lifted when the plant is soon brought into cGMP compliance.
Last week the UK's MHRA regulatory body issued a recall for 17 drugs that are produced by Wockhardt at the Waluj plant, also on cGMP concerns. An import alert also was issued in Great Britain.
Some of the issues that were noted in the MHRA import alert included risks of cross contamination, due to poor cleaning, and also defects in building materials and in the ventilation systems. There also was evidence that some documents had been forged in the area of staff training.