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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
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
Oculus Innovative Sciences has received 510(k) clearance for its Microcyn hydrogel for scars resulting from burns, surgery or trauma wounds, with the FDA recognizing the device as substantially equivalent to similar products. Read More
Angelcare is voluntarily recalling its Movement and Sound Monitors with Sensor Pads due to the risk of a pliable cord wrapping around a baby’s neck in the crib. Read More
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 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
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