On Oct. 17 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 told two Chinese drug facilities that it plans to refuse admission to their pharmaceutical products, in two warning letters sent in late September. FDA says it found violations of current good manufacturing practice (CGMP) regulations for pharmaceuticals at a China Resources Sanjiu (999) Medical and Pharmaceutical Co., Ltd. located in Shenzhen (here). It also said the facility is unregistered because the company changed locations without amending its registration. As a result, FDA is already refusing shipments of pharmaceuticals from the facility. In a separate letter, FDA notified Beijing Shunxin Meihua Bio-technical Co., Ltd. that it has been placed on three import alerts because it refused or limited an inspection by FDA officials (here). Additionally, from the documents it was able to review, the agency said it found the company is being supplied with crude heparin by another company that is already on an import alert for the pharmaceutical product.
On Oct. 16 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 issued its weekly Enforcement Report for Oct. 15 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.
Nine health and environment advocacy groups sent a petition to the Food and Drug Administration on Oct. 15, urging the agency to ban some chemicals in food packaging that allegedly cause brain damage to fetuses and infants, along with other pregnancy complications. The food additive, perchlorate, prevents the body from processing iodine, which is critical in making hormones, said the petition to the FDA Office of Food Additive Safety. The groups also asked the FDA to ban perchlorate used as “a conductivity enhancer in the manufacturer of antistatic agents in contact with dry food and as additive to sealing gaskets for food containers." The Natural Resources Defense Council, Center for Food Safety, Breast Cancer Fund, Center for Environmental Health, Environmental Working Group, Improving Kids’ Environment, Clean Water Action, Center for Science in the Public Interest and Children’s Environmental Health Network signed the petition.
On Oct. 15 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
During the week of Oct. 6-12, the Food and Drug Administration modified the following existing Import Alerts (not otherwise listed on the FDA's new and revised import alerts page) on the detention without physical examination and/or surveillance 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:
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: