Kimberly-Clark received a Form 483 after investigators from the FDA’s Dallas district office found it did not retest product lots manufactured on two lines that were involved in earlier findings of contamination. Read More

Medtronic is conducting a voluntary Class I recall of multiple guidewires used to place diagnostics and interventional devices in the coronary and peripheral blood system. Read More

San Diego-based Avacen received a nine-citation FDA warning letter for not having established a host of essential GMP procedures. The company makes The Avacen Thermal Exchange System, or TATES. Read More

CME America failed to investigate the adequacy of its device labeling following three MedWatch reports on administration sets that related to the way a customer was using the device, according to a Form 483 issued to the Golden, Colo., devicemaker. Read More

Manufacturers should use a two-step approach to grade nonconforming products — a matrix for determining the initial number, followed by escalations to set a final grade, according to a proposed guidance released last month by the Asian Harmonization Working Party. Read More

Devicemakers that operate in Brazil should be checking to see that none of their business holdings has been charged with corrupt practices — either in Brazil or elsewhere in the world, experts warned during a recent American Bar Association meeting devoted to the country’s new antibribery law. Read More

A series of joint assessments of EU device notified bodies found a “generally satisfactory” level of compliance with legal requirements and best practices, but revealed multiple issues with organizational requirements and quality management systems, according to an interim report by the Notified Bodies of Government. Read More

An interim report on the joint assessments of EU device notified bodies (NBs) shows there is room for improvement in the planning, scope and depth of surveillance activities. Read More

Avacen, maker of The Avacen Thermal Exchange System (TATES), was hit with a nine-citation FDA warning letter for failing to establish a host of essential GMP procedures. Read More

Manufacturers should use a two-step approach to grade nonconforming products — a matrix for determining the initial number, followed by escalations to set a final grade, according to a proposed guidance released last week by the Asian Harmonization Working Party. Read More