The Food and Drug Administration recently warned owners of a beef producer, a dairy, and a frozen food company about violations of federal food safety laws.

Food companies that receive FDA warning letters have 15 days to respond. Companies that do not respond, or those that submit responses describing inadequate correction measures, face regulatory action by FDA without further notice. Those actions can include, without limitation, seizure and injunction. Warning letters released by FDA in recent days include the following.

Alle Processing Corp., Maspeth, NY
In an Oct. 26 warning letter to company president Aaron Hollander, the FDA cited “significant deviations” at the Alle Processing Corp. facility in Maspeth, NY. The company produces shelf-stable and frozen low-acid foods.

Inspectors documented “a temperature inaccuracy during re-calibration of one Mercury In Glass thermometer that resulted in the potential under-processing of all LACF (low-acid canned foods) products manufactured by (the) firm between approximately Feb. 1, 2016 through Feb. 19, 2017.” 

The thermometer was showing temperatures that were off by 4 degrees F compared to the required minimum public health sterilizing requirements, which can result in dangerous bacterial growth and other foodborne pathogens.

“As a result of this instrument temperature inaccuracy, your firm did not deliver the minimum time/temperature critical limits identified in your LACF products filed scheduled processes for any LACF products manufactured between approximately Feb. 1, 2016, through Feb. 19, 2017,” according to the warning letter.

Inspectors also found the company’s thermometers were overdue for calibration, which can result in inaccurate readings as were observed during the FDA inspection.

“It should also be noted that this is a repeat observation from the previous FDA inspection, conducted on Aug. 12, 2015, wher we found a MIG thermometer installed on Retort #5 that was overdue for calibration. The tag on the unit indicated that it was last calibrated on ‘1/30/2014’ and that it was due for calibration on ‘1/30/15,’ ” according to the warning letter.

Another problem pending since 2015 involves Alle Processing Corp. failing to meet federal law that requires food manufacturing companies to report new processes to the FDA. 

Specifically, the company implemented a new process schedule, developed in August 2015, for the manufacture of shelf-stable gefilte fish in jelled broth without telling the FDA about the changes. Inspectors cited concerns about heat penetration during the fish production process.

Welter Farms Inc., Holy Cross, IA
In a Nov. 27 warning letter to owners Nicholas S. Welter, Randy Welter and Dan Welter, the FDA cited Welter Farms Inc. for selling a cow for slaughter as human food that had illegal levels of a sulfonamide antibacterial in its tissues.

The FDA’s investigators visited Welter Farms on July 18, 18 and 20 this year. The investigation revealed that, on March 29, the farm delivered a beef steer  for slaughter as food that had illegal levels of sulfamethazine. Long Prairie Packing Co. in Long Prairie, MN, slaughtered the animal March 30.

“U.S. Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of sulfamethazine at 0.756 parts per million (ppm) in the liver, and 0.533 ppm in the muscle,” according to the FDA warning letter. “FDA has established a tolerance of 0.1 ppm for residues of sulfamethazine in the edible tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), 556.670 (21 C.F.R. § 556.670).  The presence of this drug in edible tissues from this animal above the tolerance causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. § 342(a)(2)(C)(ii).”

Investigators also cited Welter Farms for holding animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. The FDA staff found the farm’s operators failed to maintain any physical or written records for its beef cattle regarding treatment of injured or sick cattle. And, the owners did not have required records regarding the identity, purchase, or sale of cattle.

Jelliffe Dairy Farm, Asbury, NJ
In a Nov. 19 warning letter to Jake and Debra Jelliffe, the FDA cited Jelliffee Dairy Farm for selling a bob veal calf for slaughter as food that had illegal antibiotic residues in its tissues. The FDA’s inspectors visited the dairy farm on July 31 and Aug. 3 and 10 this year.

The dairy owners had sold the calf on June 5. It was slaughtered June 8 and the USDA’s Food Safety and Inspection conducted routine testing. The tests revealed the presence of 10.9 parts per million (ppm) of neomycin residue in the kidney. 

“…there is no acceptable level of residue associated with the use of the drug neomycin in bob veal calves (pre-ruminating calves),” according to the FDA’s warning letter. The letter says label instructions on the medication specifically state “do not use in calves to be processed for veal.”

The dairy owners had used neomycin in buckets of milk in mixed-sex pens of calves. The calves shared the buckets, thus consuming the medication. The drug is only intended for use in heifer calves.

“… you do not individually identify your cattle in a way that would permit you to track them through drug treatment and/or sale, you failed to maintain treatment records, and you lack an adequate inventory system for determining quantities of drugs used to medicate your animals,” the FDA warning letter states.

“Our investigation also found that you hold animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. You lack an adequate system to ensure that animals medicated by you have been withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous residues of drugs in edible tissues.”