Another Ranbaxy facility stopped from making APIs for U.S.
The FDA is prohibiting Ranbaxy Laboratories from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, in order “to prevent substandard quality products from reaching U.S. consumers,” according to a news release.
The FDA is prohibiting Ranbaxy Laboratories from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, in order “to prevent substandard quality products from reaching U.S. consumers,” according to a news release.
The agency inspected the Toansa facility in mid January and found significant violations of current good manufacturing practice (CGMP) requirements. Staff of the facility had retested raw materials, intermediate drug products, and finished API after they had already failed analytical testing and specifications. The staff members wanted to produce acceptable findings and did not report or investigate the failures, according to FDA.
“Ranbaxy will not be permitted to resume manufacturing and distributing API for FDA-regulated drugs from the Toansa facility until the agency is satisfied that Ranbaxy has addressed its manufacturing quality issues at that facility,” FDA noted.
A third-party expert must be used to inspect the Toansa facility at Ranbaxy’s expense in order to certify that the facility is in compliance with CGMP.
For additional information on FDA’s regulatory activities for Ranbaxy, go to FDA’s website.
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