On April 26 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On April 25 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 threatened to refuse imports from seafood processors in Morocco and Argentina because of alleged deficiencies in the hazard analysis and critical control point (HACCP) plans. Because of the alleged deviations, fish and fishery products from Moroccan processor CONSERNOR S.A. (here) and Argentine processor Pranas S.A. (here) are adulterated, FDA said. An inadequate response to the warning letters may result in the two facilities’ fish products being placed on detention without physical examination, the agency said.
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 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).
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.
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:
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:
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:
The Food and Drug Administration issued a draft guidance on container and carton labeling for prescription drugs and biological products. The draft guidance focuses on how to design container labels and carton labeling in ways that minimize medication errors.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.