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Circle Prime Manufacturing has received a Form 483 after an FDA inspection revealed inadequate records, complaint procedures and a failure to describe its vendor rating criteria. Read More
Circulatory Technology Inc. received a Form 483 for failing to submit a medical device report (MDR) in a timely manner, properly evaluate an MDR event, establish a design history file, establish adequate design plans and properly investigate complaints. 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 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
Final FDA guidance updating device reporting requirements clarifies the obligations of contract manufacturers and makes other welcome changes to the March 2013 draft version. Read More
Industry representatives have endorsed measures that would streamline the FDA’s premarket review process, but said they will be watching closely for tangible results in exchange for a $320 million increase in user fees. Read More