On Oct. 11 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Oct. 10 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
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.
On Oct. 9 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Oct. 8 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Oct. 7 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
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.
On Oct. 4 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
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.
The Food and Drug Administration warned California seafood importer Jin Han International that it may seize or refuse its entries at the border for violations of the hazard analysis and critical control point regulations, in a letter sent to the company Sept. 25. According to the FDA warning letter, Jin Han, which does business as Pacific Foods Co., failed to make sure its imported product is processed in accordance with HACCP regulations. It also didn’t get product specifications from several manufacturers, so it can’t ensure those products aren’t injurious to health or produced under insanitary conditions.