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Home » Topics » Medical Devices » Quality

Quality
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Avacen Warned for Lack of Multiple Manufacturing Procedures

December 6, 2013
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

Forgotten Documentation for Tests Brings 483 for Chase Medical

December 5, 2013
An FDA investigator handed Chase Medical a Form 483 after the company’s manufacturing assembler admitted she does not always remember to document all in-process tests for the Tripod Heart Stabilizer devices. Read More

Kimberly-Clark Form 483: Should Have Retested Lots

December 5, 2013
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 Faces Class I Guidewire Recall

December 5, 2013
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

FDA Warns Avacen Over Multiple Missing Manufacturing Procedures

December 5, 2013
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 Gets 483 for Failure to Look Into Labeling After Complaints

December 5, 2013
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

AHWP Issues Harmonized Guidance on Product Nonconformities

December 5, 2013
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

Brazil’s New Anti-Bribery Law Has Consequences for Industry, Experts Warn

December 4, 2013
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

EU is ‘Raising the Bar’ on Notified Bodies, Joint Audits Report Shows

December 4, 2013
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

FDA Officials to Speak at Human Factors Workshop

December 2, 2013
EU devicemakers will have a chance to speak directly with top FDA officials at a three-day workshop on human factors for medical devices scheduled for April 1-3, 2014. Read More

Joint Audits of Notified Bodies Show EU Is ‘Raising the Bar’

November 27, 2013
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 Warned for Lack of Multiple Manufacturing Procedures

November 27, 2013
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
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