FDA Finds Flaw In Abbott's Manufacturing

16 January 1995

The US Food and Drug Administration has found a wide range of flaws in Abbott Laboratories' quality assurance procedures used in assembling medical diagnostic products, reports the Wall Street Journal.

The FDA findings have reportedly led the agency to hold up approval of some of the firm's diagnostic devices. The agency focuses on what is termed a "looseness" in the company's quality control methods.

In response to the FDA comments, Abbott said that it has instituted a global plan covering practices at its plants in Chicago, Dallas and Santa Clara. The agency is to reinspect the company's facilities over the next few weeks to see if the faults have been remedied.

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