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Clinical trial sponsor Brava was hit with an FDA warning letter over several informed consent violations and conflict-of-interest issues related to evaluations of its fat micro grafting device. Read More
The FDA has requested a meeting with Express Diagnostics International, as well as an independent audit of the company’s manufacturing practices, following an inspection that uncovered problems with testing and labeling of the company’s products. Read More
The FDA on Thursday launched a new data dashboard, providing a more user-friendly way for manufacturers to obtain inspection and recall data. Read More
The number of devicemakers receiving FDA warning letters following quality system inspections decreased 12 percent in 2013, compared with 2012 — the first decline since 2009. There were 144 warning letters with quality system regulation deficiencies in 2013, compared with 164 a year earlier. Read More
The FDA has issued a warning letter to Vention Medical’s Costa Rica facility for violations of environmental controls, equipment upkeep and other quality issues. Read More
The FDA is telling Health Science Products to get certification from an outside expert, after the company purchased components from unqualified suppliers. Read More
The FDA has warned Winter Park, Fla., devicemaker Iradimed for failing to initiate and validate corrective actions related to its infusion pumps and sets. Read More
As notified bodies in the EU conduct the first wave of unannounced quality audits of devicemakers, they are building profiles of the companies to determine when and how often they are inspected in the future. Read More
St. Jude Medical has resolved good manufacturing practice issues that had plagued its Plano, Texas, neuromodulation facility, leading to a 2009 warning letter. Read More
Medtronic Ireland failed to submit MDR reports within 30 days of becoming aware of an event, including two that involved the death of a patient, according to a May 15 Form 483, recently released. Read More