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.