On May 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 its weekly Enforcement Report for May 8 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.
On May 7 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 posted transcripts and archived webcasts of its meeting on the Food Safety Modernization Act proposed rules on product safety and preventative controls in human food, held in Washington, D.C., Feb. 28-March 1. FDA already posted presentations from the session (see 13031417).At the meeting, FDA officials discussed the proposals, asked for comments, and responded to questions on the rules. FDA also held meetings in Chicago and Portland on the food safety rules (see 13020627).
The Food and Drug Administration issued the April Interstate Certified Shellfish Shippers List (ICSSL). The ICSSL is published monthly for the information and use by food control officers, the seafood industry and other interested persons. The shippers listed have been certified by regulatory authorities in the U.S., Canada, Chile, Korea, Mexico and New Zealand under the uniform sanitation requirements of the National Shellfish Program.
The Food and Drug Administration is proposing to reclassify ultraviolet tanning lamps from class I to class II. The reclassification would make the tanning lamps subject to premarket notification, and would designate special controls the agency deemed necessary for safe use. FDA would also change the name of the products from “ultraviolet lamps for tanning” to “sunlamp products.” Comments on the reclassification, which is being proposed on FDA’s own initiative, are due by Aug. 7.
The Food and Drug Administration may refuse admission of imports of pharmaceuticals from Canada-based CMI Cosmetic Manufacturers, the agency said in a warning letter dated April 25. According to the letter, a recent FDA inspection found violations of current good manufacturing practice requirements at the Concord, Ontario facility. The company also failed to register with FDA, but still offered its pharmaceuticals for import into the U.S., the agency said.
Care Diagnostica’s devices are subject to import refusal for violations of current good manufacturing practice requirements, said the Food and Drug Administration in a warning letter dated April 23. The Moellesrsdorf, Austria company has 15 days from receipt of FDA’s letter to correct the violations.
On May 6 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 an order debarring David Freeman for five years from providing services to any person that has an approved or pending drug product application, in connection with his 2010 conviction for introducing and delivering into commerce a misbranded drug. Along with his accomplice Ashley Brandon Foyle, Freeman imported omeprazole from Muhi Trading Corporation, and his company Omega Biotech had repackaged and sold the drug. Neither Freeman, Omega, or Muhi Trading were registered to manufacture, prepare, propagate, compound, or process drugs, FDA said. The agency already published an order debarring Foyle on May 1 (see 13043018).