FDA Warns 5 European & Asian Device Companies for CGMP, MDR Violations
The Food and Drug Administration sent warning letters to five foreign device manufacturers in Europe and Asia, detailing various violations of current good manufacturing practices and Medical Device Reporting regulations. The warned companies include TMS International (here) of the Netherlands;…
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Energist Limited of the U.K. (here); Meridian AG of Switzerland (here); Hangzhou Jinlin Medical Appliances of China (here); and Tianjin Hanaco Xingda Medical of China (here). Energist was also ordered to cease and desist marketing in the U.S. of its “Ultra Plus VPL for ‘skin rejuvenation’” because it is allegedly being marketed for unapproved uses.