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Combining various risk metrics into a single number can help manufacturers rank suppliers according to risk and identify those that might need to be dropped. Read More
Best Medical Canada landed a Form 483 for not establishing adequate complaint procedures or ensuring that its devices conformed to specifications. Read More
The FDA has reclassified antigen-based rapid influenza virus antigen detection test systems (RIDTs) from Class I to Class II devices and has introduced special controls aimed at improving the quality of testing. Read More
FDA inspectors hit Covidien with a Form 483 for inadequate complaint evaluation and process control procedures, as well as failure to ensure appropriate design and installation of manufacturing equipment. Read More