Teleflex, a global provider of medical technology products, has received approval of all remaining requests of certificates to foreign governments (CFG) from the FDA.
Beginning in the third quarter of 2010, Teleflex has 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 substantially corrected the quality system issues identified in the corporate warning letter.
While Teleflex continues to believe it has substantially remediated the issues raised in the corporate warning letter through the corrective actions taken to date, the letter remains in place pending final resolution of all outstanding issues, which the company is actively working with the FDA to resolve.
Teleflex enables healthcare providers to improve patient outcomes, reduce infections and support patient and provider safety. Teleflex also has niche businesses that serve segments of the aerospace and commercial markets with specialty engineered products.