FDA Says Baxter Medical Device Label is False and Misleading

The labeling for an unspecified medical device made by Baxter International Inc. is false and misleading and the company has failed to follow manufacturing guidelines for the product, the Food and Drug Administration said.

The FDA sent a warning letter to the company after a series of inspections of Baxter plants and offices in California, Illinois, and German between April and June 2009 uncovered quality-control problems, according to a report in The Wall Street Journal.

Product safety officials did not identify the Baxter medical device that prompted the FDA concerns but said the company failed to adequately address or fully investigate manufacturing problems the agency previously identified.

The FDA also said Baxter’s response to the agency’s initial inspection concerns was inadequate.

“Management with executive responsibility failed to ensure that the quality policy is understood, implemented, and maintained at all levels of the organization,” the agency said in the warning letter sent to Baxter Sept 10.

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