Teleflex announces receipt of approval of all certificates to foreign governments from FDA
Teleflex Incorporated (NYSE: TFX) today announced that it has received approval of all remaining requests of certificates to foreign governments (“CFG”) from the FDA.
Beginning in the third quarter of 2010, the Company began submitting requests for CFGs to the FDA for review. The Company believes that the FDA’s approval of these CFGs is a clear indication that it has substantially corrected the quality system issues identified in the corporate warning letter.
While the Company continues to believe it has substantially remediated the issues raised in the corporate warning letter through the corrective actions taken to date, the corporate warning letter remains in place pending final resolution of all outstanding issues, which the Company is actively working with the FDA to resolve.
About Teleflex Incorporated
Teleflex is a global provider of medical technology products that enable healthcare providers to improve patient outcomes, reduce infections and support patient and provider safety. Teleflex, which employs approximately 12,600 people worldwide, also has niche businesses that serve segments of the aerospace and commercial markets with specialty engineered products. Additional information about Teleflex can be obtained from the Company's website at www.teleflex.com.
Forward-Looking Statements
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements. Any forward-looking statements contained herein are based on our management’s current beliefs and expectations, but are subject to a number of risks, uncertainties and changes in circumstances, which may cause actual results or company actions to differ materially from what is expressed or implied by these statements. These risks and uncertainties are identified and described in more detail in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K.