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The European Medicines Agency is seeking information on an implant sold by a Medtronic unit after inspectors determined that a U.S.-based supplier of an active substance for the product had deviated from good manufacturing practices. Read More
The FDA has warned AG Industries on medical device reporting failures related to a complaint of a mini-nebulizer shocking a child and other good manufacturing practice violations. Read More
Following the outbreak of infections related to a deadly superbug, the FDA has provided new guidelines to help healthcare facilities ensure their duodenoscopes are cleaned adequately. Read More
Belgium-based Euromi was slapped with a far-ranging FDA warning letter that chides the company for not properly handling complaints, including instances in which cannula tips from a liposuction system broke and became lodged in patients. Read More