On Dec. 10 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 recently threatened four foreign seafood processors with import alerts for failure to follow food safety and labeling regulations, in warning letters sent in November. In two warning letters sent on Nov. 24, FDA told Cau Tre Export Goods Processing of Vietnam (here) and Crimasa Criaderos De Mariscos (here) that violations of the hazard analysis and critical control point regulations at each company’s facility may result in detention without physical examination for their crab and shrimp products. FDA also sent a letter Nov. 14 warning of a possible import alert for similar violations at a facility in Spain owned by Balfego and Balfego (here). The agency told all three companies that their U.S. agents may be assessed fees for any necessary reinspections. FDA also warned Salazones Garre of Spain on Nov. 6 that its dried tuna product may be subject to detention without physical examination for violations of labeling rules (here)
On Dec. 9 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 Dec. 1-7, 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 Dec. 8 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 final rule to establish Jan. 1, 2018, as the uniform compliance date for food labeling regulations that are issued between Jan. 1, 2015, and Dec. 31, 2016 (here). FDA periodically announces uniform compliance dates for new food labeling requirements to minimize the economic impact of label changes. (FDA previously established Jan. 1, 2016, as the uniform compliance date for food labeling regulations issued between Jan. 1, 2013, and Dec. 31, 2014.)
The Food and Drug Administration on Dec. 9 issued new guidance on the labeling of prescription drug and biological products. In “Patient Counseling Information Section of Labeling for Human Prescription Drug and Biological Products--Content and Format” (here), FDA provides guidance on how to decide what topics to include in the patient counseling information section, as well as how to present information and organize the section, it said.
On Dec. 5 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 Dec. 3 that lists the status of recalls and field corrections for food, drugs, biologics, and devices (here). The report covers both domestic and foreign firms.
On Dec. 4 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: