Glaxo, Jazz Pharmaceuticals Cited by FDA

GlaxoSmithKline and Jazz Pharmaceuticals were both cited by the U.S. Food and Drug Administration (FDA) over a number of violations. The Jazz Pharmaceutical plant in California and the GlaxoSmithKline facility in the United Kingdom are involved.

The FDA sent a warning letter to Jazz Pharmaceuticals Inc. over concerns about violations at its California plant, said Bloomberg Businessweek, which noted that shares for the pharmaceutical manufacturer dropped 6.2 percent following the FDA’s warning letter was released. The letter, dated October 11, cites Jazz Pharmaceuticals for not reporting 74 serious drug side effect and injury reports, said Businessweek. Companies are federally mandated to submit adverse event reports within 15 days of receipt.

The agency provided a number of examples to Jazz in which patients reported taking Xyrem, a medication prescribed for “excessive sleepiness,” and that involved unreported adverse events from January 2003 and December 2010, said Businessweek. The FDA inspectors also found that Jazz never developed written procedures for how to monitor and submit adverse events. Businessweek noted that Jazz Pharmaceuticals received a similar citation in September 2007.

In response to the recent citation, Jazz issued a statement that it has been working “diligently” to address the agency’s concerns and that it has been working on this issue since April, when it says it was first advised of the matter, Businessweek reported. “We look forward to responding quickly to this warning letter and demonstrating our compliance to FDA’s satisfaction,” the company said in its statement.

Meanwhile, in March, the FDA’s inspection of GlaxoSmithKline’s Worthing plant—SmithKline Beecham—revealed microbiological contamination and problems with laboratory control procedures, said In-Pharma Technologist. The FDA found that a so-called “media fill” completed in January 2011 revealed two contaminated units, said In-Pharma Technologist. A media fill is a microbiological test meant to simulate routine manufacturing conditions by replacing a pharmaceutical product with a culture medium to verify that Good Manufacturing Practices are in place.

According to the FDA, Glaxo said the failures were due to stopper bags left within a class 100 area for a long period of time, said In-Pharma Technologist. The FDA also said that data about the microorganisms recovered from the stopper bags, as well as information on the sterility test were lacking, and that Glaxo’s plans to use media fill data to lengthen “sterility holding times for product contact components,” were completed without “the approval of [the]quality unit,” In-Pharma Technologist reported.

Lab issues were also indicated. “Please review all the out of specification investigations for product within expiration date to determine if the investigation procedures were properly followed,” said the FDA, In-Pharma Technologist wrote, adding that microbiological contamination and lab control procedures as well as other problems upon visual inspection were found.

Businessweek explained that the FDA routinely distributes warning letters to firms found not to be following established regulations for manufacturing, marketing, and testing. While not legally binding, the FDA can take the firms to court if the letters are ignored

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