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:
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. 7 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
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 won’t be accepting facility registrations for drug and device production and distribution facilities during the federal government shutdown, despite the beginning of the registration period Oct. 1. All drug and device facilities that market their products in the U.S. are required by law to register, including foreign facilities whose drugs and devices are imported into the U.S. But without a fiscal year 2014 budget, FDA said it has no legal authority to collect user fees associated with the registrations. The drug and device facility registration period runs until Dec. 31. The registration user fee for FY 2014 is $3,313.
The Food and Drug Administration may refuse entry to Australian company Flavour Makers’ acidified sauces, and will charge reinspection fees, for violations of the agency’s acidified food regulations, FDA said in a warning letter dated Sept. 12. The violations found during an inspection in January were “materially related” to food safety, so FDA will have to reinspect the facility to ensure the problems were fixed. FDA suggested the Australian company notify its U.S. agent, who will be liable for the fees.
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.
The Food and Drug Administration threatened a German generic drug manufacturer with refusal of their imports at the border for failure to register and pay new fees required for generic drugs for fiscal year 2013. In a warning letter sent Sept. 17, FDA said C.P.M. Contract Pharma failed to comply with self-identification and facility fee requirements set by the Generic Drug User Fee Amendments of 2012. Because FY 2013 ended Sept. 30, FDA said it will not take enforcement action for failure to identify for that year if Contract Pharma completes its FY 2014 GDUFA self-identification submission within 15 days of receipt of the warning letter.
On Oct. 3 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: