The Food and Drug Administration (FDA) issued the December 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.
On Dec. 7 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Dec. 6 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
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. 5 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.
A new guidance is available for small business compliance with labeling and testing requirements for over-the-counter sunscreen drug products, said the Food and Drug Administration. The guidance summarizes FDA’s June 17, 2011 final rule on the subject, which: (i) required that OTC sunscreen drug products follow Drug Facts labeling content and format requirements; (ii) Established new labeling requirements for marketed OTC sunscreen drug products; and (iii) Revised SPF, broad spectrum, and water-resistant testing requirements and the indications and claims allowed based upon the results of these tests.
The Food and Drug Administration detailed a laundry list of violations by drug manufacturer Shanghai Huhui Daily Use Chemical Products Co., in a warning letter sent Nov. 14. Specific violations included violations of current good manufacturing practice regulations, and misbranded over the counter drugs because of incorrect labeling. The company also offered its products for sale in the U.S. from 2009 to 2012 without registering with FDA. Until all violations have been corrected, FDA may refuse imports from the manufacturer, it said.
The Food and Drug Administration threatened two fish processors from the Philippines with detention without physical examination of their fish products for failure to comply with the seafood Hazard Analysis and Critical Control Point regulation. The warning letters said tuna products from Blue Marine Seafoods Trading (here) and Sol Fish Traders (here) are adulterated in that they have been prepared, packed, or held in a way that might prove injurious to health. The import alert conveying information on detention without physical examination of products that do not conform with the seafood HACCP regulation can be found here.
The Food and Drug Administration sent warning letters to device manufacturers in the United Kingdom (here) and China (here), threatening withholding of approval for Class III devices related to the violations. FDA cited CASMED International of the UK, and Shanghai Ruike Sports Goods of China, for violations of the current good manufacturing practices of the Quality System regulation. Shanghai Ruike was also cited for failure to comply with Medical Device Reporting regulations.
During the week of Nov. 26 - Dec. 2, 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: