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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
Dental products manufacturer Insert Depot received a Form 483 for not properly reviewing complaints, lacking device history records, failing to establish procedures for design control and failing to ensure equipment is routinely calibrated, inspected and maintained. 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
Failure to properly record complaint investigations and document evaluations of potential suppliers brought an FDA warning letter to a New Jersey manufacturer of filtration systems. Read More
The FDA slapped a warning letter on a California manufacturer of balloon catheters and inguinal hernia implants for not adequately evaluating complaints to determine device failure. 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
With a number of attempted and successful cyberattacks making headlines, what steps can medical devicemakers take to ensure the security of their products? Read More