The Food and Drug Administration posted new and revised versions on Dec. 26 of the following Import Alerts on the detention without physical examination of:

The Food and Drug Administration posted new and revised versions on Dec. 21-22 of the following Import Alerts on the detention without physical examination of:

The Food and Drug Administration recently posted a list of the most common entry errors for imports of medical devices. From October 2016 through March 2017, 45 percent of all validation errors detected by FDA’s PREDICT system were caused by the firm name on the entry not matching the firm name on file for the listing number transmitted, followed by the registration number on the entry not matching the registration number for the listing number, at 18.3 percent. Another common error was no registration number transmitted for the foreign manufacturer or device exporter, at 7.8 percent, FDA said.

On Dec. 20 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 Dec. 20 that lists the status of recalls and field corrections for food, drugs, biologics and devices. The report covers both domestic and foreign firms.

On Dec. 19 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

On Dec. 18 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The Food and Drug Administration outlined a new risk-based enforcement policy for unapproved homeopathic drugs, in a draft guidance issued Dec. 18. Under the new policy, if finalized, FDA will prioritize enforcement on unapproved drugs labeled as homeopathic based on their risk to human health, though “any product labeled as homeopathic that is being marketed illegally is subject to FDA enforcement action at any time,” the agency said. Comments are due March 20, FDA said in a concurrent notice in the Federal Register.

On Dec. 15 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

On Dec. 14 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: