FDA Warns Chinese & Japanese Device Companies for CGMP Violations
The Food and Drug Administration warned Chinese and Japanese device manufacturers that their products do not conform to current good manufacturing practice (CGMP) requirements of the Quality System regulation, in two warning letters dated Nov. 13. Premarket approval applications for…
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related devices, and Requests for Certificates to Foreign Governments, will not be approved until Chinese company A&D Electronics (Shenzhen) (here) and Japanese company Osachi (here) correct the violations, FDA said. In its warning letter to Osachi, FDA also said the company’s devices are misbranded because it has no written Medical Device Reporting procedures.