FDA Threatens Indian Drug Company With Import Refusal; Second Warning in Five Months
The Food and Drug Administration threatened to refuse imports of pharmaceuticals manufactured at two Indian facilities owned by Wockhardt Limited, in the second warning letter sent to the company in under five months. FDA’s second letter, dated Nov. 25, once again detailed violations of current good manufacturing practice requirements at Wockhardt facilities located in Chikalthana and Waluj, Maharashtra.
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“It is apparent that Wockhardt is not implementing global and sustainable corrective actions,” said FDA in the letter. “It is essential that your firm implement a robust quality system. We remind you that you are responsible for ensuring that your firm’s drug manufacturing operations comply with applicable requirements and produce acceptable quality drugs,” the agency said. “FDA strongly recommends that Wockhardt’s executive management immediately undertake a comprehensive and global assessment of your manufacturing operations to ensure that your systems and processes, and ultimately, the drug products you manufacture, conform to FDA requirements for safety, efficacy, and quality.”
To that end, FDA recommended Wockhardt hire a third-party auditor with experience in detecting data integrity programs to help with compliance. Two of the four violations alleged in the letter concerned storage of data and access to it. FDA said it may refuse entry to drugs manufactured at Wockhardt’s Chikalthana and Waluj facilities until the violations are corrected.