FDA: Baxter Resolved Warning Letter For Belgium Facility
March 24 2010 - 1:14PM
Dow Jones News
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;
jon.kamp@dowjones.com
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