On June 3 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 may refuse entry to drug products manufactured at Novartis’ Ebewe Pharma facility in Austria, alleging that a drug produced at the facility is unapproved for U.S. distribution. According to the FDA warning letter, Novartis distributed the drug without the required FDA marketing application. The agency also alleged violations of current good manufacturing practice requirements at the facility.
On May 30 - June 2 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On May 30 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On May 29 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 a proposed rule requiring domestic tobacco product importers and manufacturers to submit user fee calculation information. The information is currently collected by the Department of Agriculture, but in October 2014 they will cease collection, ceding the task to the FDA. The proposed rule is intended to ensure the agency collects information necessary to make allocations among tobacco product classes, and individual domestic importers and manufacturers within each class, FDA said.
The Food and Drug Administration finalized its requirement that prior notice submissions for imported food name any countries where the food shipment has been refused entry. The final rule adopts a May 2011 interim rule, without change, amending 21 CFR 1.281 (see 11050516). The requirement has been in effect since July 3, 2011, as required by Section 304 of the Food Safety Modernization Act.
On May 28 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 May 21-28, 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:
On May 24 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: