During the week of May 7-13, 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 added two new documents providing Affirmation of Compliance codes for use with FDA regulation products, CBP said in a CSMS message (here). The new guides are available (here). The codes are used to show that a product identified in an FDA line meets certain requirements, said CBP. Though use of the codes if voluntary, the data can expedite screening and further review of an entry, said CBP.
On May 10-12 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On May 9 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On May 8 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 May 8 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.
On May 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 issued the April Interstate Certified Shellfish Shippers List (ICSSL). The ICSSL is published monthly for the information and use by food control officers, the seafood industry and other interested persons. The shippers listed have been certified by regulatory authorities in the U.S., Canada, Chile, Korea, Mexico and New Zealand under the uniform sanitation requirements of the National Shellfish Program.
Care Diagnostica’s devices are subject to import refusal for violations of current good manufacturing practice requirements, said the Food and Drug Administration in a warning letter dated April 23. The Moellesrsdorf, Austria company has 15 days from receipt of FDA’s letter to correct the violations.
The Food and Drug Administration may refuse admission of imports of pharmaceuticals from Canada-based CMI Cosmetic Manufacturers, the agency said in a warning letter dated April 25. According to the letter, a recent FDA inspection found violations of current good manufacturing practice requirements at the Concord, Ontario facility. The company also failed to register with FDA, but still offered its pharmaceuticals for import into the U.S., the agency said.