On June 4 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
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:
During the week of May 29 - June 3, 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 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.
Food and Drug Administration export certificates for U.S. cosmetic products are now only available online, the agency said. Beginning June 3, paper cosmetic export certificates are no longer available. According to the FDA, the switch from a paper-based system to a web-based system will make the application process more efficient for exporters and the agency. Export certificates are provided to foreign importers of U.S. cosmetic products, and may be required by foreign governments. Certificates are available through the FDA Certificate Application Process website. Exporters can create an account (here). An example of the new certificates and the new “Certificate Identifier” are (here). Frequently asked questions on cosmetic export certificates are (here).
The Food and Drug Administration will continue to refuse entry of a drug product packaged at Contract Pharmaceutical Services of Australia’s North Ryde facility, it said in a warning letter. A previous FDA inspection found current good manufacturing practice violations that still haven’t been corrected, and the firm also failed to register, the agency said. FDA redacted the name of the drug subject to import refusal in the letter.
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.