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TÜV Rheinland has scored another victory in a French court in a case involving faulty breast implants. However, its fate in another case is up in the air as it awaits a decision from the European Court of Justice. Read More
A Virginia maker of implants used in plastic surgery was slapped with a warning letter after an FDA inspection found flaws with the company’s validation and MDR reporting practices. Read More
Inspectors from the FDA’s Florida district office found a pattern of missing or faulty records of supplier audits at a Clearwater, Fla.-based Soft Computer Consultants, leading to an eight-observation Form 483 for the company. The company also received a Warning Letter from the FD 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
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
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 FDA banned imports of Doro’s Evacu B wheeled stretchers for infants, after a Nov. 10 to 13, 2014, inspection found serious GMP violations that were noted in a Form 483 to the company. Read More
GMP violations including failure to submit a premarket approval application for its denture liner and failure to register the device in 2015 prompted an FDA warning letter to Better Health Systems. Read More