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:
During the week of July 28 - Aug. 3, 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 Aug. 1 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 July 30 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 intends to exempt a lengthy list of Class II and “reserved” Class I medical devices from premarket notification requirements, it said in a draft guidance issued Aug. 1 (here). The agency says the devices “are sufficiently well understood and do not present risks that require premarket notification” under Section 510(k). FDA says it will eventually issue an order in the Federal Register exempting the devices. But in the meantime, FDA says it will not enforce premarket notification requirements for the devices. Comments on the draft guidance are due Sept. 30, said FDA in a concurrent Federal Register notice (here).
On July 30 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 set potential fiscal year 2015 fees for import reinspections, domestic and foreign facility reinspections, and recall activities performed by FDA if a firm fails to comply with a mandatory recall order, though it still isn't invoicing for services associated with the fees. The agency set FY 2015 fees of $217/hour for domestic services and $305/hour if foreign travel is required. Last year, the agency set FY 2014 at $237/hour and $302/hour, respectively. The fees are effective Oct. 1.