FDA Warns Canada, UK Device Manufacturers for CGMP and MDR Violations
The Food and Drug Administration sent warning letters to Canadian and U.K. device manufacturers, citing violations of current good manufacturing practice requirements and Medical Device Reporting regulations. Usine Rotec International of Canada (here) and A C Cossor and Son (Surgical)…
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of the U.K. (here) were warned after their responses to the findings of FDA inspections were deemed inadequate. FDA will not grant premarket approval applications and requests for certificates for foreign governments until the violations are corrected, it said.