During the week of Jan. 14-20, 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 Jan. 18-21 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 issued a final rule clarifying application of current good manufacturing practice (CGMP) requirements to combinations comprised of drugs, devices, and/or biological products. Depending on the form of combination, CGMP requirements will: (1) apply to each constituent part separately; or (2) satisfy CGMP or quality system regulation requirements for another constituent part if applied to one constituent part. The final rule is effective July 21.
On Jan. 17 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Jan. 16 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 entry of German drug manufacturer Hameln Pharmaceuticals’ drug products for current good manufacturing practice regulation violations, it said in a warning letter (here). The refusal would only apply to the company’s Hameln, Germany facility, the agency said. FDA may also withhold approval of new applications or supplements listing Hameln Pharmaceuticals as manufacturer if the violations aren’t corrected.
The Food and Drug Administration may refuse imports from device manufacturers from the U.K., Korea, and Israel for current good manufacturing practice requirement violations, it said in several warning letters. Central Surgical of the UK (here), Interojo of Korea (here), and Curatonic of Israel (here) were named in the letters. FDA also took Curatonic to task for unapproved marketing of its devices. Richway of Korea (here) was also sent a warning letter for CGMP violations, but FDA stopped short of threatening refusal of its imports.
The Food and Drug Administration may refuse entry of fish products from two Canadian processors for violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations, it said in two recently published warning letters. North Fish’s HACCP plans are inadequate for salted herring, dried salted white fish, and refrigerated cold smoked mackerel, rendering those products adulterated, FDA said (here). Fisherman's Market’s mackerel, mahi mahi, marlin, herring, shad, tuna, and vacuum packaged frozen cooked lobster, crab and shrimp products are adulterated for the same reason, it said (here).
On Jan. 15 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Jan. 14 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: