Pennsylvania's Teleflex has successfully resolved all issues raised in an FDA warning letter received by its subsidiary, Arrow International, back in October 2007. The letter identified the agency's observations on a variety of quality systems control measures that occurred prior to Teleflex's acquisition of the company.
"Upon receiving the Warning Letter shortly after our acquisition of Arrow, our organization immediately went to work to address the FDA's observations," said CEO Benson Smith in a statement. "In the process of responding to the Warning Letter, we applied our standards to the entire Arrow organization. Today, the resolution of this issue represents the successful execution of our response to the Agency and illustrates our commitment to ensuring that our systems and procedures across all of our global facilities continue to provide the highest quality medical products for critical care procedures and surgery."
Teleflex provides medical devices used in critical care and surgery, serving healthcare providers in more than 130 countries with specialty devices for vascular access, general and regional anesthesia, urology, respiratory care, cardiac care and surgery.
- see Teleflex's statement