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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
Nomax received a warning letter for failing to evaluate complaints, document corrective and preventive actions, and committing other violations. Read More
Zimmer Biomet’s Warsaw, Ind., medical device facility was hit with a massive, 58-page Form 483 arising from an inspection carried out from September to November of 2016. Read More
The China Food and Drug Administration (CFDA) has issued new guidance on quality control, finished product inspection, and other procedures for medical devices Read More
The FDA and the Department of Homeland Security have flagged cybersecurity weaknesses in some St. Jude Medical implantable cardiac devices used with the company’s Merlin@home transmitters. Read More
Acumedia Manufacturers was cited in a Form 483 for inadequate corrective and preventive action procedures, failing to report a correction or removal, and other violations. Read More