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FDA Warns Device Facilities in Canada, China and Japan for CGMP Violations
October 11, 2013 by Brian Feito|FDA

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

FDA Import Review Continues; Other Services at Reduced Levels, Some Consolidation Between Ports
October 8, 2013 by Brian Feito|FDA

Food and Drug Administration Import Operations staff are continuing to perform their import review functions during the federal government shutdown, but the agency is working at reduced service levels for inspections and other activities, said United Parcel Service (UPS) Supply Chain Solutions in an update emailed Oct. 7. FDA is consolidating work at some FDA ports of entry during the shutdown. For example, FDA Alexandria Bay, N.Y. clearances will be handled by FDA Ogdensburg, N.Y., the update said.

FDA to Bar Imports from Chinese Device Facility for Numerous Violations
October 7, 2013 by Brian Feito|FDA

The Food and Drug Administration will refuse imports of “vaginal pessary (luna beads)” devices from Chinese manufacturer Suzhou Armocon Technology Co.’s Jiangsu facility after finding a litany of violations, it said in a warning letter dated Sept. 16. The company failed to meet current good manufacturing practice requirements and didn’t comply with medical device reporting requirements for either the luna beads or its “Tor II” penile ring devices, the agency said. FDA said the Suzhou Armocon didn’t secure premarket approval from FDA for its luna beads, and also made unfounded health claims for the product, including that they can be used for Kegel workouts “with proven health benefit for women of all ages,” to “prepare for a healthier pregnancy and easier postnatal recovery,” and to “significantly reduce chances of incontinence and pelvic floor disorders.” Finally, the company didn’t list either device in its annual registration.