FDA Warns Device Facilities in Canada, China and Japan for CGMP Violations
The Food and Drug Administration sent warning letters to device companies in Canada, China, and Japan, citing violations of current good manufacturing practice requirements at facilities owned by Batrik Medical (here), Anji Zhengbang Medical (here), and NIDEK (here), respectively. The…
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.
letters, all sent between Sept. 19 and Sept. 24, gave each company 15 business days to fix the problems found during FDA inspections.