On April 24 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 24 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.
The Food and Drug Administration is extending until Sept. 16 the comment periods for its proposed rules on produce safety (here) and preventative controls for human food (HARPC) (here). The proposals, which implement provisions of the Food Safety Modernization Act, were originally issued Jan. 16 (see 13010429 and 13010805, respectively). FDA also extended the comment period until Sept. 16 for its draft risk assessment for activities conducted in on-farm facilities (here).
On April 23 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On April 22 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 15-21, 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The Food and Drug Administration issued a draft guidance on container and carton labeling for prescription drugs and biological products. The draft guidance focuses on how to design container labels and carton labeling in ways that minimize medication errors. Comments on the draft guidance are due by June 24.
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:
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 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.