Animas Receives FDA Warning Letter

WEST CHESTER, Pa.–(BUSINESS WIRE)–March 2, 2005–Animas Corporation (NASDAQ:PUMP), a leading manufacturer of insulin pumps, reported today that, on February 28, 2005, it received a Warning Letter from the Philadelphia District Office of the Food and Drug Administration. The Warning Letter, which was dated February 24, 2005, was issued after the inspection of its West Chester facility in the fall of 2004. The letter concerns procedures and implementation of corrective and preventative action under Current Good Manufacturing Practices (CGMP) requirements, as well as the acquisition and reporting of information required under the Medical Device Reporting (MDR) regulation. Animas is committed to working cooperatively with the FDA to resolve the matters in the FDA letter.

About Animas Corporation: Animas, a leading maker of insulin infusion pumps and related products, is dedicated to improving diabetes management and making insulin pump therapy easier for patients with insulin requiring diabetes and healthcare professionals through product innovation, exemplary customer support and superior customer education. For more information on Animas, visit or call Animas Corporation at 877-937-7867.

This news release contains a forward-looking statement, regarding Animas working to resolve the matters in the FDA letter. This forward-looking statement involves risks and uncertainties and is subject to change. There can be no assurance that there will not be further FDA actions. Readers are referred to the reports and documents filed from time to time by Animas Corporation with the Securities and Exchange Commission for a discussion of these and other important risk factors. Readers are cautioned not to place undue reliance on forward-looking statements, which are made as of the date of this press release. Animas Corporation undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or for any other reason.


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