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A high-precision compounding and dispensing device used to mix two solutions together received a warning letter following an inspection that revealed a failure to maintain procedures for validating the device design. Read More
A Colorado device maker has received a Form 483 after investigators witnessed supplier observations and quality system issues. In total six observations were listed. Read More
A response to a Form 483 is not a routine or informal communication and should be given the same attention and care you would give to defending your company from a federal indictment — because that’s what a 483 actually is. Read More
Fujifilm Medical Systems U.S.A., Inc. failed to investigate complaints about a device failure, establish procedures for evaluating complaints and taking corrective and preventive action, fail report a correction or removal, and adequately validate a process, according to a Form 483. Read More
Failure to report a design change and to conduct proper design validation for its porcine xenograft particulate in syringe landed Collagen Matrix an FDA warning letter. Read More
The FDA has released draft guidance on product labeling for ultrasonic surgical aspirator devices that it says will contribute to their safe and effective use. Read More
A March FDA inspection revealed that Bellus Medical marketed and distributed its SkinPen device without approved premarket clearance or an investigational device exemption. Read More
A federal appeals court has upheld an injunction against wholesalers’ U.S. sales of Abbott Laboratories’ “FreeStyle” blood glucose test strips that were bought overseas at discount prices. Read More