Teleflex Incorporated (NYSE: TFX) today announced that it has received approval of a significant number of additional certificates to foreign governments ("CFG") from the FDA, totaling forty-one approvals out of eighty-five submitted requests.
“I am very pleased by today's announcement”
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 and continues to anticipate receiving the FDA's approval with respect to most of these requests in the third quarter of 2010.
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.
"I am very pleased by today's announcement," stated Jeffrey P. Black, Chairman and Chief Executive Officer. "The receipt of additional CFG approvals from the FDA will allow us to continue to provide critical medical devices that will enhance patient care in emerging markets and further our efforts to drive sustainable and profitable growth."