FDA Threatens 3 Device Manufacturers from UK, Korea & Israel with Import Refusal
The Food and Drug Administration may refuse imports from device manufacturers from the U.K., Korea, and Israel for current good manufacturing practice requirement violations, it said in several warning letters. Central Surgical of the UK (here), Interojo of Korea (here),…
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and Curatonic of Israel (here) were named in the letters. FDA also took Curatonic to task for unapproved marketing of its devices. Richway of Korea (here) was also sent a warning letter for CGMP violations, but FDA stopped short of threatening refusal of its imports.