On Aug. 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 will allow use of vitamin D3 as a food additive in certain meal replacement beverages, it said in a final rule that takes effect Aug. 12. The agency says it will allow Vitamin D3 as a nutrient supplement, subject to limitations on the total amount, in meal replacement beverages that are not intended for special dietary use in reducing or maintaining body weight and for use in foods that are sole sources of nutrition for enteral feedings. Objections and requests for hearings are due Sept. 11.
On Aug. 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 issued its weekly Enforcement Report for Aug. 6 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 York seafood importer faces import alert and possible seizures after the Food and Drug Administration found it to be in violation of seafood hazard analysis and critical control point (HACCP) regulations, according to an agency warning letter dated July 22. FDA says it refused admission of an entry imported by H.A.R. Maspeth Corp. after routine sampling detected salmonella. A subsequent inspection found that the company isn’t taking action to ensure the dried squid it imports is processed in accordance with seafood HACCP rules, said FDA. The agency warned H.A.R. Maspeth that if the violations aren’t corrected, the company’s seafood imports may be detained without physical examination or seized. FDA also said it may assess fees to cover the costs of any reinspection to verify compliance.
On Aug. 6 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Aug. 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 threatened to refuse imports from two food canneries based in Poland for violations of food safety regulations, it said in two separate warning letters sent July 17. FDA said its inspectors found violations of the low-acid canned foods, acidified foods, and emergency permit control regulations at an Agro-Serwis facility in Sucha Beskidzka (here). In another warning letter, the agency said it found violations of the low-acid canned foods and emergency permit control regulations at an Provitus Dabrowscy, Malesa S.J. facility in Zambrow (here). FDA said it may place products from the two facilities on import alert and detain without physical examination. The agency also said it would have to conduct a reinspection to verify compliance. Because the violations are related to food safety the agency will assess fees on the two companies’ U.S. agents, said FDA.
The Food and Drug Administration recently sent warning letters to seafood processors in Japan and Peru threatening detention of their fish products at the border unless violations of seafood hazard analysis and critical control point (HACCP) regulations are corrected. In a letter sent to Inversiones Peru Pacifico dated July 14, FDA cited problems with the company’s mahi mahi products processed at its Sullana, Peru facility (here). In another warning letter dated July 7, FDA told Marutoshi that bonita tuna flake products from its Kagoshima facility are adulterated because of HACCP violations (here). The agency threatened to place both on import alert and detain affected fish products without further examination. It also said it would collect reinspection fees from the companies’ U.S. agents for any reinspection conducted to verify compliance.
On Aug. 4 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: