A ready-to-eat salad manufacturer, a seafood processor, a dairy and a swine operation were the recipients of recently posted warning letters from the U.S. Food and Drug Administration. Reser’s Fine Foods Inc. of Beaverton, OR, was told July 1 by FDA’s Atlanta District Office that an inspection last fall of its salad production facility in Halifax, NC, revealed three different Listeria strains and that the bacteria had likely been present there since November 2013. FDA also noted several serious violations of Current Good Manufacturing Practices at the North Carolina plant involving inadequate cleaning and sanitizing of utensils and equipment. Food Safety News detailed the contents of the warning letter to Reser’s in a story posted July 28.

Skipanon cannery
Workers at the Skipanon cannery in Warrenton, OR, process fish.
On June 23, FDA’s Seattle District Office sent a warning letter to Skipanon Brand Seafoods LLC noting problems with seafood Hazard Analysis and Critical Control Points (HACCP) and product labeling that inspectors found during 13 different inspection dates in 2015 of the firm’s processing facility in Warrenton, OR. The warning letter pointed out “serious violations” of federal seafood HACCP regulations, rendering as adulterated the company’s Frozen Canned Albacore Tuna and Frozen Canned and Smoked Albacore Tuna. Investigators collected labels of various Skipanon products during their visits, which revealed additional problems, the warning letter noted. “Our review of the labels indicate that your firm’s ‘Albacore Tuna,’ ‘Smoked Peppered Chinook Salmon,’ ‘Smoked Chinook Salmon,’ ‘Chinook Salmon,’ ‘Smoked Sockeye Salmon,’ and ‘Smoked Coho Salmon’ products are misbranded …,” FDA stated, detailing issues with appropriate serving size, percent daily values and other label format requirements. The agency received Skipanon’s response to the inspection, dated Nov. 30, 2015, plus its reconditioning proposal dated Dec. 9, 2015, along with revised product labels. However, FDA found the responses inadequate because, among other things, the company’s “… new plans do not list the critical control point of smoking for controlling the food safety hazard of scombrotoxin (histamine) formation.” Record-keeping deficiencies were also mentioned in the warning letter, specifically time and temperature observations during various processing stages “to control for the hazard of histamine formation listed in your HACCP plans for Frozen Canned Albacore Tuna and Frozen Canned and Smoked Albacore Tuna, respectively.” FDA acknowledged that Skipanon shut down processing operations from Nov. 9-23, 2015, as a result of an inspection conducted by the Oregon Department of Agriculture. The department issued a cease-and-desist order to the company on Sept. 25, 2015, and ordered a product embargo on Sept. 28. In October 2015, Skipanon recalled all lots and all sizes of its canned seafood products because of inadequate documentation and potential under-processing, posing a botulism risk. There were at least 16 subsequent secondary recalls but no reported illnesses. dairy-cows-rear-viewFDA’s Kansas City District Office sent a warning letter on June 21 to Kohman Dairy LLC following a May 11-13 visit to the operation in Syracuse, KS. The letter stated that a cow sold for slaughter on or about March 9 had 21.02 parts per million (ppm) of Sulfamethazine in the liver tissue. FDA has established a tolerance of 0.1 ppm for residues of Sulfamethazine in the edible tissues of cattle. “The presence of this drug in edible tissue from this animal in this amount causes the food to be adulterated …” under federal law, the warning letter stated. Monroe Grain & Supply Inc. of Monroe, IN, was sent a warning letter from FDA’s Detroit District Office on June 29. Investigators visiting the firm’s swine operation from Jan 28 through Feb. 18  found violations of the Federal Food, Drug, and Cosmetic Act, the letter stated. Specifically, a hog sold for slaughter as food on or about Aug. 31, 2015, was found to have sulfadimethoxine in its kidney tissue. However, “FDA has not established a tolerance for residues of sulfadimethoxine in swine. The presence of this drug in edible tissue from this animal causes the food to be adulterated …,” the agency wrote. Recipients of FDA warning letters have 15 working days from receipt to respond with details of the procedures they have taken, or will take, to correct the current violations and prevent them from recurring. (To sign up for a free subscription to Food Safety News, click here.)