FDA Sends Warning Letter to Teleflex

Teleflex Inc. received a warning letter from the Philadelphia District Office of the U.S. Food and Drug Administration regarding one of its new subsidiaries, Arrow International, a maker of catheter and therapeutic products for critical and cardiac care, and the company’s facilities in the United States. The FDA’s letter indicates the agency is concerned about several of Arrow’s quality systems and advises that Arrow’s corporate-wide program to evaluate, correct and prevent quality system issues has been deficient. Arrow received three site-specific warning letters in 2005 and subsequent inspections were performed from June 2005 to February 2007 at Arrow facilities. The warning letter does not impose additional sanctions that are expected to have a material financial impact on the company, Teleflex (NYSE:TFX) said in a statement. Teleflex said Arrow has been actively working to address the FDA’s findings and has been conducting a thorough review of its quality systems. Teleflex acquired Arrow International on Oct. 1 and its integration plan includes the commitment of significant resources to correct these previously identified regulatory issues and further improve overall quality systems, the company said. Teleflex is a Limerick, Pa.-based diversified company that designs and makes products for the aerospace, commercial and medical industries. It also said that it has signed an agreement to sell its business units that design and manufacture automotive and industrial driver controls, motion systems and fluid handling systems to Kongsberg Automotive Holding ASA for $560 million in cash. Kongsberg is a leading global automotive supplier in Kongsberg, Norway. SOURCE: Philadelphia Business Journal