Beginning in the third quarter of 2010, Teleflex began submitting requests for CFGs to the FDA for review. The company believes that the FDA’s approval of the CFGs is a clear indication that it has 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 the requests in the third quarter of 2010.
Teleflex continues to believe that it has 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.
Jeffrey Black, chairman and CEO, said: “I am very pleased by 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.”
