Indian drugmaker Wockhardt (BOM: 532300) on Wednesday revealed that it had received another US Food and Drug Administration warning letter for its active pharmaceutical ingredient plant in Ankleshwar, Gujarat.
This is part of the "same process" of an earlier import alert the company received from the US regulator for the same facility. "The company has already initiated required steps to address the concerns raised by US FDA and is putting all its efforts to resolve the same," Wockhardt said in a statement to stock exchanges.
In the FDA warning letter, the FDA said its investigator observed specific violations and deviations including, but not limited to, the following.
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