FDA Warns Device Facilities in Germany, Switzerland and Korea for CGMP Violations
The Food and Drug Administration sent warning letters to three device manufacturers in Germany, Switzerland, and Korea, detailing violations of current good manufacturing practice regulations by each facility. FSSB Chirurgische Nadeln of Germany (here), and Tecval Medical of Switzerland (here),…
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were each warned by FDA that premarket approval applications and requests for certificate to foreign governments may be denied until their violations are corrected. Given the “serious nature” of violations by Sometech Incorporated of Korea (here), FDA will keep that company’s products on import alert, it said.