On Jan. 7 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 is establishing a list U.S. milk product manufacturers and processors interested in exporting to China, according to a Jan. 7 update from the agency’s Center for Food Safety and Applied Nutrition. The list will be used to help U.S. manufacturers comply with the Chinese government’s new requirements for importing milk products into China. The Chinese government has said milk products from manufacturers and processors that are not on FDA’s list could be denied entry into China, said FDA.
During the week of Dec. 30 - Jan. 5, 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:
The Food and Drug Administration threatened to refuse imports from seafood processors in Chile, India, and El Salvador, in three recent warning letters sent by the agency. According to the letters, FDA found violations of seafood hazard analysis and critical control point (HACCP) requirements in facilities owned by Comercial Comtesa of Chile (here), Parayil Food Products of India (here), and Acpetamar of El Salvador (here). The agency’s inspection of Parayil also turned up violations of FDA’s emergency permit control and acidified food regulations, it said.
The Food and Drug Administration issued its weekly Enforcement Report for Jan. 1 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.
The Food and Drug Administration will refuse entry of Cavi-Lipo devices from South Korean device manufacturer SkinRex because it is being marketed for unapproved uses, said the Food and Drug Administration in a warning letter dated Dec. 12. Although electric therapeutic massagers are exempt from premarket notification, SkinRex is marketing its Cavi-Lipo device for use in the treatment of cellulite, and compares the treatment to liposuction in its marketing materials. As such, the device needs premarket approval from FDA, which SkinRex did not obtain, said the agency. FDA said it is “taking steps to refuse entry of these devices in the United States” through detention without physical examination.
On Jan. 2 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Dec. 31 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Dec. 30 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Dec. 27 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: