FDA Warns Chinese, UK Device Manufacturers for CGMP Violations
The Food and Drug Administration sent warning letters to device manufacturers in the United Kingdom (here) and China (here), threatening withholding of approval for Class III devices related to the violations. FDA cited CASMED International of the UK, and Shanghai…
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Ruike Sports Goods of China, for violations of the current good manufacturing practices of the Quality System regulation. Shanghai Ruike was also cited for failure to comply with Medical Device Reporting regulations.