FDA Warns Taiwan Device Manufacturer for CGMP Violations
The Food and Drug Administration said it may reject premarket approval applications and refuse to issue certificates to foreign governments for Grantech of Taiwan after finding violations of current good manufacturing practices at the medical device company’s Taipei facility. According…
Sign up for a free preview to unlock the rest of this article
If your job depends on informed compliance, you need International Trade Today. Delivered every business day and available any time online, only International Trade Today helps you stay current on the increasingly complex international trade regulatory environment.
to FDA, the company’s first response was inadequate. But two responses by the company went unreviewed because of late submission, FDA said.