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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
South Korean devicemaker Nuga Medical received an FDA warning letter related to a host of GMP woes, including design control and CAPA procedures. 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
Devicemakers in China can expect surprise inspections from that country’s Food and Drug Administration starting Sept. 1, according to recently released guidance. Read More
The UK’s Medicines and Healthcare products Regulatory Agency has successfully prosecuted two companies it says supplied defective prefilled syringes whose use resulted in a diabetic patient’s death in 2010. Read More
A recent survey showing that device company executives are often unaware of problems faced by their quality control units may point to an overlooked contributing factor in FDA warning letters, an expert says. Read More