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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
Aptalis, a specification developer for the Flutter mucus clearance device, failed to report a contract manufacturer’s rework of devices to correct issues both this year and in 2012, a recent FDA warning letter says. The company also did not record its justification for that decision. 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
Faced with long waits for Brazilian good manufacturing practice certificates, some devicemakers are turning to the courts to speed up product registrations — and seeing their time to market cut in half, an expert says. Read More
The FDA has released a previously announced warning letter to spine implant maker Globus Medical, citing the company for releasing five lots of MicroFuse putty that did not meet its own specification for mechanical testing. Read More
The International Medical Device Regulators Forum adopted four final guidance documents and two new work items relating to the Medical Device Single Audit Program during a meeting in Brussels last month. 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