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The FDA has warned Ambco Electronics after the devicemaker failed to correct deficiencies noted during a California Department of Public Health inspection and an earlier FDA inspection. Read More
The FDA Tuesday unveiled a broad plan that will change the way it inspects devicemakers, handles recalls, issues and reviews enforcement decisions and screens imports, with companies likely to start feeling the impact by the end of 2015.
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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