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The FDA and Brazil’s National Surveillance Agency have added new auditing bodies to their list of organizations eligible to conduct quality management system audits for the Medical Device Single Audit Program. Read More
The FDA issued warning letters to four device manufacturers for a range of issues, including a failure to seek pre-market approval, to apply for modified intended uses, and quality violations. Read More
Florida-based Biolife drew a Form 483 with four observations following a June 2017 FDA inspection. The investigator flagged the Sarasota facility’s inadequate design change documentation and medical device reporting procedures. Read More