FDA warns Wockhardt on quality issues

The US Food and Drug Administration (FDA) has issued a warning letter to Wockhardt on certain deviations from its quality manufacturing norms at the company's plant at Waluj in Aurangabad.

"Failure to correct these deficiencies may result in FDA denying the entry of articles manufactured by your firm into the USA. The articles could be subject to refusal of admission pursuant to Section 801 (a)(3) of the Federal Food, Drug, and Cosmetics Act ," the US FDA letter stated.

The USFDA letter, sent in February, has pointed out that the inspection at this plant had revealed "significant deviations from the US Current Good Manufacturing Practices (CGMP) in the manufacturing of drugs and active pharmaceutical ingredients (APIs)."

When contacted Wockhardt spokesperson said the Waluj plant was yet to produce drugs for the US market.

"The team of FDA officials inspected this plant and later sent a letter on February 21. Wockhardt has already complied with most of these observations. In its latest communication dated April 4, the USFDA had acknowledged Wockhardt's efforts and we are confident that this facility will be approved by the US FDA in the near future," he added.