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The FDA has hit Cepheid with a warning letter for not taking corrective actions to deal with good manufacturing practice deviations at its Solna, Sweden facility. Read More
The FDA has warned AG Industries on medical device reporting failures related to a complaint of a mini-nebulizer shocking a child and other good manufacturing practice violations. Read More
The FDA has cited data integrity as one of the most important GMP issues because it lies at the crux of all GMP systems. John Avellanet, managing director and principal at Cerulean Associates, sat down with FDAnews to talk about how companies should be handling their data.Read More
FDA handed devicemaker Synovis a Form 483 for not initiating corrective and preventive actions for nonconformities to its Terminally Sterilized Vascu-Guard patch. Read More
Improving inspection activities and concentrating on postmarket surveillance to enhance patient safety are two areas where Brazil’s Agência Nacional de Vigilância Sanitária made strides in 2014, according to a new report. Read More
Olympus is facing tough questions from the FDA following inspections conducted in April and May of four facilities that manufacture duodenoscopes. The company — along with Pentax and Fujifilm — is facing scrutiny after improper cleaning of its complex endoscopes was linked to patients becoming sick or dying. Read More
Devicemakers in China can expect surprise inspections from that country’s Food and Drug Administration starting Sept. 1, according to guidance. Read More
The FDA handed Siemens Medical Solutions USA a Form 483 for failing to report device malfunctions that could present health risks on at least four occasions between 2011 and 2014. Read More
Medical device maker ZYTO Technologies received an FDA warning letter May 8 for labeling and promotion issues that stemmed from a Dec. 3, 2014, 11-item Form 483 for numerous quality system deviations. Read More
The FDA slapped Houston, Texas-based Trilliant Surgical with a five-item FDA-483 that highlighted numerous lapses in corrective and preventive actions following an inspection covering Jan. 16, 2015 to Feb. 12, 2015. Read More