W
ockhardt has been asked by America’s Federal Drug Administration (FDA) to conduct a global assessment of its plants to ensure that the drug produced by the company conforms to FDA requirements for safety, efficacy, and quality. Questioning the reliability and accuracy of tests conducted by Wockhardt, the FDA in a letter expressed concerned about its inability to implement a robust and sustainable quality system. It is apparent that Wockhardt is not implementing global and sustainable corrective actions. It is essential that your firm implement a robust quality system.
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