On April 15 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On April 12 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 recently posted a new webpage on its additional import authorities under a law enacted in October. The Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (aka, the Support Act), enacted Oct. 24, 2018, makes improvements to the infrastructure and resources of international mail facilities (IMFs), and grants FDA new authorities related to active pharmaceutical ingredients and drugs from importers with a pattern of violations.
Correction: On April 10 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of (see 1904110008):
On April 10 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 April 10 that lists the status of recalls and field corrections for food, cosmetics, tobacco products, drugs, biologics and devices. The report covers both domestic and foreign firms.
The Southern Shrimp Alliance in an April 10 email released updated data on shrimp entries rejected by the U.S., the European Union and Japan. The SSA database now includes information from calendar year 2018 on U.S. Food and Drug Administration entry line refusals, the EU's Rapid Alert System for Food and Feed (RASFF) notices and Japan’s Ministry of Health, Labour and Welfare, Imported Foods Inspection Services (IFIS). During 2018, the FDA refused 53 entry lines of shrimp due to antibiotics, 23 of which came from China and 15 from India. The "RASFF included another fourteen (14) notices of shrimp refused entry into the European Union because of banned antibiotics," the SAA said. "All but one of these refusals was of shrimp shipped to Europe from India." In Japan, "IFIS reported refusing twenty (20) shipments of shrimp because of the presence of banned antibiotics last year, all originating either from Vietnam (16) or India (4)."
On April 9 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On April 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 removed about 9 percent of medical device facility registrations from its database in March, Registrar Corp. said in a blog post. That’s likely because those approximately 2,551 establishments did not renew their registrations by Dec. 31, the annual deadline for facility registration renewal, the consultancy said. “When a registration is deactivated, so are the active listings associated with the registration. All propriety names and importers will be removed from the listings,” Registrar Corp. said. “Marketing a medical device in the U.S. without a valid registration and listing is a prohibited act and may result in costly detentions or refusals. Many facilities do not realize their registration is invalid until problems like these occur,” it said. “Facilities whose registrations have been removed will be required to reactivate their registration and device listings with FDA.”