On April 19-21 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 will continue to refuse admission into the U.S. of drug products manufactured at Kanebo Cosmetics’ Odawara Japan facility, the agency said in a warning letter. According to FDA, an inspection found “significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals.” The agency recommended the company find a third-party consultant with CGMP expertise to assist in bringing the facility into compliance.
On April 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 issued its weekly Enforcement Report for April 17 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.
On April 17 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 is proposing to allow symbols on labeling for medical devices and biological products, as long as the symbol has been established as part of a standard developed by a nationally or internationally-recognized standards development organization. The standardized symbol will have to be part of a standard recognized by FDA for use on medical devices, and it would have to be explained in a symbols glossary that accompanies the device, the agency said. FDA is also proposing to allow the statement “Rx only” on the labeling of prescription devices. Comments on information collection aspects of the proposed rule are due by May 20, and comments on all other parts of the proposal are due by June 18.
On April 16 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
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:
During the week of April 8-14, 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 will begin its month-long reporting period for generic drug facility self-identification for fiscal year 2014 on May 1. Between May 1 and June 1, generic drug facilities, certain sites, and organizations identified in a generic drug submission are required to submit, update, or reconfirm identification information to FDA, it said. More information, including generic drug facilities that have to register, is available (here).