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…
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letters, all sent between Sept. 19 and Sept. 24, gave each company 15 business days to fix the problems found during FDA inspections.