FDA: Baxter Resolved Warning Letter For Belgium Facility

Baxter International Inc. (BAX) has addressed problems the Food and Drug Administration found at a company plant in Belgium, resolving a warning letter the FDA issued the company in January, according to a new letter from the agency.

The new letter, sent to Baxter Chief Executive Robert L. Parkinson, Jr., on Monday and posted on the FDA's Web site, said the agency completed its evaluation of Baxter's corrective actions, and that "it appears that you have addressed the violations." The agency sent the prior warning letter on Jan. 15, and Baxter disclosed the matter that month during its quarterly earnings call.

The FDA issues warning letters when it finds problems that need to be addressed in manufacturing plants and other facilities. Such letters can sometimes prove expensive and time-consuming to resolve, and can also block approvals for new products, but in this case resolution only took a couple months.

Baxter makes a plasma-derived drug called Gammagard, which is used to treat immune-system problems, at the facility in question. The FDA letter covered how the company investigated and handled issues with clogged filters used to make the biologic drug.

Baxter noted in January there were no safety issues associated with this problem.

Shares of Baxter, based in Deerfield, Ill., were recently down 0.6% to $59.02.

-By Jon Kamp, Dow Jones Newswires; 617-654-6728; [e-mail]