The Food and Drug Administration may place products from Canadian seafood processor Sambro Fisheries on detention without physical examination, effectively refusing imports from the company for violations of seafood Hazard Analysis and Critical Control Point regulations, it said in a warning letter. The company’s HACCP plan doesn’t list hazardous allergens for its tuna, marlin, and mahi-mahi, nor does it define a critical control point of refrigerated storage to control scombrotoxin formation. If the company doesn’t respond in 15 days from receipt of the letter, or FDA deems its response inadequate, FDA may refuse admission.
On March 18 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 March 11-17, 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 lengthy list of corrections to clerical errors in its Jan. 16 proposed rules on produce safety and preventative controls in human food, respectively. The corrections address typos, incorrect references, and the numbering of sections and tables, among other things. Corrections to the produce safety proposal are available (here), and corrections to the preventative controls in human food proposal are available (here).
On March 15 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 debarred Shu Bei Yuan from importing food for five years, in connection with her conviction for false labeling of honey from China in an attempt to evade antidumping duties. The debarment order is effective March 18.
On March 13 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 March 13 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 posted presentations from its Feb. 28-March 1 meeting on the recently issued proposed rules on produce safety and preventative controls for human food (HARPC) (see 13010805 and 13010429). The presentations were given by FDA officials, and include overviews of the two Food Safety Modernization Act proposed rules, their respective regulatory impacts, and educational and technical assistance related to the proposals.
On March 12 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: