The company has 15 days in which to respond to the food safety regulator and could incur enforcement action including product seizure or an injunction, claims the FDA.
The Dean Foods plant concerned is the canned food unit, Kohler Mix Specialties in Minnesota, and the FDA claims the facility did not maintain records to document sterilization cycle times and other processes.
Inadequate response
The agency stated in the letter to Dean Foods, which is published on the FDA website, that its responses to a previous FDA query regarding its sterilization processes are inadequate.
According to the FDA, the Minnesota facility’s failure to fulfil the requirements of the Canned Food regulations 21 CFR 108.35 renders its Half & Half and 18 per cent Light Cream products adulterated within the meaning of section 402(a)(4) of the Act.
This section maintains that low-acid canned foods may be adulterated if they have been prepared, packed or held under unsanitary conditions whereby they have become contaminated with filth, or whereby they may have been rendered injurious to health.
Dean Foods did not respond by publication time to a request from FoodProductionDaily.com for comment.
Kohler, whose product line consists primarily of ice cream mixes, creamers, and soy and organic milk, was acquired by Dean Foods in 2003.
HACCP violation
Meanwhile a recent injunction against a US seafood processor is a result of FDA enforcement action to protect seafood safety, claims the agency.
At the request of the FDA, the US District Court for the District of Minnesota on 17 February entered an order of permanent injunction against seafood processor, Captain's Select Seafood, of Minnesota.
The defendants are charged with repeatedly violating the Federal Food, Drug, and Cosmetic Act and the FDA's Hazard Analysis Critical Control Point (HACCP) regulations for seafood processors.
According to the food safety regulator, the court held that the evidence presented by the FDA showed a lengthy and undisputed history of violations from 2004 through at least early 2008, during which time Captain's Select did not have a HACCP plan that complied with the FDA's regulations.
Hazard control
The FDA said its HACCP regulations require that all seafood processors develop and implement adequate plans that identify all food safety hazards likely to occur for each kind of seafood product, and contain preventative measures that the processor can implement to control those hazards.
"While there are no reported illnesses associated with consuming Captain's Select Seafood products, we cannot allow a company to put the public's health at risk by not having adequate procedures and plans to produce safe food," said Michael Chappell, the FDA's acting associate commissioner for regulatory affairs.
"The FDA will take action against companies and against their executives who violate the law and endanger public health," he added.
The order of permanent injunction requires that either the FDA or a federal district court must first approve the defendants' HACCP plans before any of the defendants can resume operating any food-supply business, or any food-related business involving seafood.