Czech Company's Medical Devices Subject to Import Refusal After FDA Finds MDR, CGMP Violations
The Food and Drug Administration warned a device manufacturing facility in the Czech Republic that its products may be subject to import refusal and detention without physical examination, because of violations of Medical Device Reporting and current good manufacturing practices…
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regulations. The warning letter, dated Dec. 12, said Biotronik Fortress Introducer Sheath System devices, manufactured by Contract Medical International, are misbranded and adulterated. Although the company has responded to FDA’s findings, it did not include adequate supporting documentation.