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FDA warning letters: Salmonella risk, pests, undeclared gluten

A shell egg farm in Missouri, a cheese manufacturer in Texas, and a bakery in Florida were recipients of the most recently posted food-related warning letters from the U.S. Food and Drug Administration.

FDA’s Kansas City District Office wrote to Cedar Creek Egg Company LLC on Nov. 8 to say that inspections done Aug. 23-25 and Sept. 13-15 at the company’s shell egg production farm in Sainte Genevieve, MO, found “serious violations” of the federal regulations designed to prevent Salmonella Enteritidis (SE).

White Leghorn egg-laying chickens in cages in their hen house.The agency’s warning letter stated that the company failed to have and implement a written SE prevention plan as required and did not have documentation that pullets were being tested for the pathogen between 14-16 weeks of age.

In evaluating the company’s response dated Sept. 8, FDA wrote that while a SE plan was promised, the company had not provided the new plan to the agency and had not discussed procedures to make sure that pullets are raised under SE-monitored conditions, including environmental testing.

FDA also stated that biosecurity measures were necessary to protect against cross-contamination when moving between poultry houses.

“For example, there are no foot bathes (sic) at the entrance to the hen houses, dedicated boots, garments or other procedures to prevent cross contamination,” according to the warning letter.

Other problems FDA cited in the letter included not monitoring for rodents or flies in egg-laying houses, not removing vegetation and debris that may provide harborage for pests, no appropriate procedures for cleaning and disinfecting the poultry houses, and no refrigeration or cooling logs to document that eggs were held at or below 45 degrees F starting 36 hours after they are laid.

“We will evaluate the adequacy of your corrective actions during our next inspection of your farm,” the agency wrote.

goudalawsuit-iphoneDutch Farmstead Cheese was sent a warning letter on Nov. 7 from FDA’s Dallas District Office informing the company that a July 11-14 inspection of its cheese processing facility in Farwell, TX, revealed several Current Good Manufacturing Practice (CGMP) violations.

“Accordingly, we have determined that the ready to eat cheese manufactured by your firm is adulterated” within the meaning of the Federal Food, Drug, and Cosmetic Act, FDA wrote.

Specific violations included an employee observed discharging whey from a cheese vat onto the floor, thereby potentially providing nutrients for microbial growth in the pitted and cracked floor, according to the warning letter.

FDA also noted inadequate screening or protection against pests, “as evidenced by the large numbers of flies observed throughout the facility, including in the packaging and production areas.”

Rodenticide bait blocks were seen in the packaging room, FDA wrote. However, “the use of insecticides or rodenticides is permitted only under precautions and restriction that will protect against the contamination of food, food-contact surfaces, and food-packaging material,” the letter pointed out.

Inspectors observed high weeds adjacent to the building, building problems needing repair, sinks draining waste directly onto the production floor before flowing a few feet to the floor drain, and dripping condensate in the cheese aging room, according to the letter.

FDA also mentioned inadequate procedures for cleaning and sanitizing equipment and utensils, failure to make sure employees wash and sanitize their hands thoroughly, and failure to ensure employees who have direct contact with food, food-contact surfaces and food-packaging materials conform to hygienic practices while on duty.

“Specifically, your employee was observed wearing garments while manufacturing and packing cheese that were also worn while working in the surrounding cattle lots earlier in the day. These garments included shoes, shirt, shorts, and hat. Wearing the same garments in the cattle lots as you would in the food production area may introduce pathogenic microbial contaminants to the food production environment,” the warning letter stated.

pita-breads-iphoneOn Oct. 26, FDA’s Florida District Office sent a warning letter to Sami’s Pita Bakery Inc. describing “significant violations” of the CGMP regulations in manufacturing, packing or holding of human food found during a March 21-29 inspection of the company’s production facility in Tampa, FL.

The agency also reviewed the firm’s product labels and found violations of federal food labeling regulations, according to the warning letter.

The bakery manufactures products containing soy, wheat, and tree nuts, along with other products that do not contain any or all of those allergens, FDA wrote.

The letter stated that these products are manufactured on shared equipment, including mixers and dough dividers that are not sequenced or cleaned in between batches of products with and without those ingredients.

“FDA has received four (4) complaints between 2007 and 2016 which alleged concerns regarding the presence of gluten or wheat in products manufactured by your firm which are not listed as ingredients on the product labeling, including one consumer who stated they have Celiac disease and had a strong reaction to millet bread manufactured by your firm,” the warning letter noted.

Other issues included raw ingredient storage bins without any identifying marks, such as wheat gluten stored next to rice flour, and accumulation of filth and food residue observed on equipment within the facility, FDA wrote.

The agency also mentioned inaccurate caloric, fat, and vitamin and mineral content in the Nutrition Facts panel on the company’s labels, as well as overall label formatting problems.

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.

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