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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
The UK’s Medicines and Healthcare products Regulatory Agency should take the lead in developing a unified international approach for collecting fees related to the regulation of medical devices, a government review of the agency says. Read More
Internal audits can be a great way for a devicemaker to uncover quality issues and improve compliance programs, but there are challenges to doing them. The vast majority of manufacturers conduct internal audits soley because the FDA and ISO regulations say they should, says Susan Reilly, owner of the consultancy Reilly & Associates. That results in poorly conducted audits with little or no added value. During a recent FDAnews webinar, Reilly answered questions about how to design and perform effective internal audits. Read More
The FDA issued a warning letter to Thermedx, a Solon, Ohio-based manufacturer of gynecological and urological fluid management systems, for failing to notify the agency of device upgrades and other GMP violations. Read More