FDA to Bar Imports from Chinese Device Facility for Numerous Violations
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…
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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.