FDA to Bar Imports from China, Italy Device Factories for CGMP & Registration Violations
The Food and Drug Administration threatened two device manufacturers with refusal of their products at the border for current good manufacturing practice and registration requirements, in two agency warning letters.
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FDA’s letter to Taiwan-based San Huei United said an FDA found CGMP violations at the company’s Shenzhen, China plant (here), and said the company’s surgical masks may be subject to detention without physical examination. The company also doesn’t have premarket approval to market its device, FDA said.
FDA’s letter to U.S. device manufacturer Medtronic’s Italy-based subsidiary Invatec also cited violations of CGMP regulations, as well as violations of the Medical Device Reporting regulations (here). As a result, FDA said it will block imports of the company’s catheters.