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Utah Medical Products (UTMD) fired the latest salvo Dec. 15 in its dispute with the FDA, accusing the agency of withholding crucial documents pertinent to the ongoing lawsuit between the parties.
In an effort to jump-start its lagging third-party inspection program, the FDA recently sent a letter to Class II and Class III medical device manufacturers encouraging them to open their doors for trainee performance audits.
The Center for Biologics Evaluation and Research (CBER) issued a guidance manual Dec. 1 formalizing a systems-based approach to conducting inspections at source plasma establishments.
An inspection of Lifecore Biomedical's facility in Chaska, Minn., from April 29 to May 17 has prompted the FDA to issue a warning letter concerning the company's Gynecare Intergel Adhesion Prevention Solution.
Fischer Industries, a maker of X-ray film processors, recently received a warning letter from the FDA citing failures to keep records of device corrections or removals.
The FDA recently issued warning letters to a pair of Asian devicemakers after inspections revealed that the manufacturers weren’t complying with current good manufacturing standards.
The FDA recently issued a warning letter to Richardson, Texas-based dental products firm Dale Dental for a multitude of current good manufacturing practice violations.
The FDA recently issued a warning letter to Roche Diagnostics for failing to submit a premarket approval application (PMA) for the Tecan Clinical Workstation, which the company markets for use with certain of its diagnostic tests.
The Nuclear Regulatory Commission (NRC) has proposed a $44,400 fine against Baxter Healthcare for three violations stemming from an event earlier this year in which two workers failed to follow safety procedures when repairing a commercial irradiator at the company's Aibonito, Puerto Rico, facility.