Baxter Receives Warning Letter from FDA Regarding Gammagard Manufacturing

March 10, 2010

On January 15, 2010, Baxter Biosciences (Deerfield, IL) received a warning letter from the US Food and Drug Administration, citing significant deviations from current good manufacturing practices (cGMPs) in the manufacture of Gammagard (human immune globulin) liquid and Gammagard S/D intermediates at its manufacturing facility in Lessines, Belgium.

On January 15, 2010, Baxter Biosciences (Deerfield, IL) received a warning letter from the US Food and Drug Administration, citing significant deviations from current good manufacturing practices (cGMP) in the manufacture of Gammagard (human immune globulin) liquid and Gammagard S/D intermediates at its manufacturing facility in Lessines, Belgium.

The letter describes significant cGMP deviations identified during an FDA inspection that was conducted at the Lessines manufacturing facility between October 12 and 19, 2009.

The main deviations dealt with filters and filter clogging. The letter noted that many filter clogging events had been noted, but no actions had been put into place to correct or prevent the filter clogging.

The letter also noted that the company’s responses to purity concerns, dated November 6, 2009, and December 3, 2009, did not adequately resolve the problems.

The company was given 15 days from issuance of the letter to respond.