FDAnews Drug Daily Bulletin

WARNING LETTER THREATENS RANBAXY'S NDAS

July 6, 2006
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Manufacturing violations cited in a June 15 FDA warning letter to Ranbaxy Laboratories could result in a hold on some of the company's new drug applications (NDAs) and a U.S. ban on importation of others.

The letter, posted on the FDA website June 23, details "significant deviations" from current good manufacturing practices at Ranbaxy's facility in Paonta Sahib, India. The violations, found during a February inspection, ranged from missing data and documentation to an insufficient number of personnel testing products for stability. The prevalence of these instances "heightens our concerns regarding the conduct, adequacy and oversight of your drug product stability testing and monitoring program," the letter said.

Until the problems are fixed, the FDA's Division of Manufacturing and Product Quality will recommend that none of Ranbaxy's NDAs that list the Paonta Sahib facility as the manufacturing site of a product be approved, according to the letter. The agency could also deny all of Ranbaxy's products entry in to the U.S.

The full text of the warning letter can be seen at http://www.fda.gov/cder/warn/2006/320-06-03.pdf (http://www.fda.gov/cder/warn/2006/320-06-03.pdf).