The Food and Drug Administration threatened three food manufacturers with import refusal, and said it would collect reinspection fees, for violations of current good manufacturing practice (CGMP) regulations. Chan Yee Jai of Hong Kong (here) and Productos Alimenticios Centroamericanos of Guatemala (here) were both cited for violations of food CGMP regulations at 21 CFR 110, while COVI S.A.S. of France (here) was cited for violations of CGMP for low-acid canned food regulations at 21 CFR 113. A lack of response, or an inadequate response, will result in detention without physical examination at the border for products form each facility, FDA said.
On July 8 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 July 1-7, 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 issued its weekly Enforcement Report for July 3 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.
A new draft guidance is now available on Medical Device Reporting (MDR) adverse event reporting and recordkeeping regulations for manufacturers, said the Food and Drug Administration. Once finalized, the guidance will update FDA policy and clarify the agency’s interpretation of the MDR regulations, it said. The guidance will be available on FDA’s website (here).
On July 3 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On July 2 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On July 1 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 June 24-30, the Food and Drug Administration modified the following existing Import Alert (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 is refusing imports of pomegranate seeds from Turkish company Goknur Gida Maddeleri Ithalat Ihracat Tic (aka Goknur Foodstuffs Import Export Trading), after connecting the product to a multistate outbreak of hepatitis A that infected 56 people in seven states. The joint investigation by FDA and the Centers for Disease Control found the a single shipment of seeds was the common ingredient in Townsend Farms and Harris Teeter Organic Antioxidant Blends that were recalled in June, it said.