As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems.

Lea-Way Farm Inc. dba Blue Ridge Beef
Statesville, NC

A raw pet food company in North Carolina is on notice from the FDA after inspectors found Salmonella, E. coli. and Listeria monocytogenes in their manufacturing facility. This warning letter serves as a reminder that raw pet food products contain raw meat and should be handled no differently than other raw meat products.

In a June 26 warning letter the FDA described a Sept. 30 through Oct. 25, 2019 inspection at Lea-Way Farm, Inc.’s raw pet food manufacturing facility. During the inspection, FDA investigators found serious violations of the Current Good Manufacturing Practice Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals regulation.

The FDA’s inspection resulted in issuance of an FDA Form 483. The significant violations listed are:

  1. The firm did not examine their raw materials to ensure they were suitable for manufacturing and processing into animal food, and they did not handle them under conditions that will protect the animal food against contamination and minimize deterioration. Specifically:
  • The firm utilizes tissues from animals that have died otherwise than by slaughter in the manufacturing of pet food without first determining whether the animals suffered any type of illness, injury, and/or whether any medications may have been administered to the animals prior to their pick up from the supplier and subsequent use in manufacturing, such that tissues from the animals would be unsuitable for manufacturing and processing into their pet food.
  1. They did not construct and maintain their plant in a way that reduces the potential for contamination of animal food. Specifically:
  • The concrete floors of the kill floor (where whole animals are skinned and eviscerated), the cooler room (where carcasses are trimmed and held), and the grinder/mixing room (where pet food ingredients are ground, mixed, and packaged into finished product) are rough and pitted, with standing pools of water. These areas are not easily cleaned, creating a possible niche for undesirable microorganisms.
  1. They did not thaw their raw materials or ingredients in a manner that minimizes the potential for the growth of undesirable microorganisms. Specifically:
  • In their grinder/mixing room we observed thawing beef parts used to manufacture their pet food coming into contact with the concrete floor. As noted in violation 2, the condition of their  floors creates a possible niche for undesirable microorganisms that could contaminate the thawing ingredients.
  1. They did not take adequate precautions to ensure that their plant operations do not contribute to contamination of animal food. Specifically:
  • In the cooler, employees were observed performing sanitation procedures. Over-spray from the pressure washer was observed falling into open tubs of exposed meat held for use as pet food.
  • On the kill floor, while employees removed hides from three cow carcasses, stomach contents and fecal matter were observed spilling over onto exposed carcasses. The FDA did not observe these carcasses being rinsed before being rolled into the cooler area where the carcasses are further separated for pet food use.
  • On the kill floor and in the cooler, carcasses were observed being dragged on the floors, dropping from the railing system onto the floors and being trimmed from the floors in these rooms. As noted in violation 2, the condition of their floors creates a niche for microbial activity that could contaminate the carcasses.
  1. The firm did not maintain holding and conveying systems in a way to protect against contamination of animal food. Additionally, all plant equipment must be designed of such material and workmanship to be adequately cleanable and must be properly maintained. Specifically:
  • The overhead metal rails used to transport meat carcasses between the kill floor, cooler room and processing room were observed to be poorly maintained. When overhead rails were in use, chipping/flaking paint and product buildup was observed. Additionally, these rails are not easily cleanable due to the chipping/flaking paint.
  1. The firm did not keep their plant physical facilities in good repair to prevent animal food from becoming adulterated. Specifically:
  • On the kill floor, deteriorating, exposed insulation was observed in the ceiling directly over where exposed beef carcasses are trimmed and separated for pet food.
  • The cooler unit in the cooler room was observed to be in poor repair and dripping condensate directly into tubs of open, exposed beef leg bones, shanks, and neck bones used to manufacture pet food.
  1. The firm’s facility does not have plumbing designed, installed, and maintained to properly convey sewage and liquid disposable waste from the plant and to avoid being a source of contamination to animal food or creating an unsanitary condition. Specifically:
  • The hand washing sinks located on the kill floor and the cooler room did not have adequate plumbing hook-ups to prevent water from running directly onto the floor. As noted above, carcasses used to manufacture pet food are dropped, dragged, and trimmed on these floors.

The presence of undesirable microorganisms in their pet food is further evidence of their significant CGMP violations.

During our inspection, FDA collected final product and raw ingredient samples for microbiological samples. Sample #1098421 consisted of an in-process sample of raw ground beef intended to be used as an ingredient in your firm’s finished product. This sample was found to be positive for Salmonella London Group B1 and generic E. coli. Sample #1098422 of a finished product sample of Blue Ridge Beef Raw Kitten Grind was found positive for Salmonella Agona Group B and Listeria monocytogenes Type One.

The full warning letter can be viewed here.

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