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 viewing for weeks or months after they are sent. Business owners have 15 days to respond to FDA warnings. Warnings are often not issued until the company is given months to fix the problem.

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

A raw pet food company in North Carolina was notified by the FDA after the inspector was found Salmonella, E. coli. and Listeria monocytogenes at their manufacturing facility. This warning letter serves as a reminder that raw pet food products contain raw meat and must be handled no different from other raw meat products.

In a June 26 warning letter, the FDA described inspections from 30 September to 25 October 2019 at Lea-Way Farm, a raw animal food manufacturing facility. During inspections, FDA investigators discovered serious violations of the Current Hazard Analysis of Good Manufacturing Practices, and the Risk-Based Prevention Control for Food for Animal regulations.

FDA inspection results in the issuance of Form FDA 483a. The significant violations listed are:

  1. Companies do not inspect their raw materials to make sure they are suitable for manufacturing and processing into animal food, and they do not handle them under conditions that will protect animal foods from contamination and minimize damage. In particular:
  • The company uses tissue from dead animals other than by being slaughtered in making pet food without first determining whether the animal is suffering from any kind of illness, injury, and / or whether there is a drug that might have been given to animals before they chose. rising from suppliers and subsequently used in manufacturing, so tissue from animals is not suitable for manufacturing and processing into their pet food.
  1. They do not build and maintain their plants in a way that reduces the potential for animal food contamination. In particular:
  • Concrete floors from slaughter floors (where all animals are skinned and their stomachs are removed), cooling rooms (carcasses are trimmed and held), and grinding / mixing rooms (where pet foodstuffs are ground, mixed, and packaged into finished products) rough and pitted , with standing puddles. These areas are not easy to clean, creating possible niches for unwanted microorganisms.
  1. They do not dilute their raw materials or ingredients in a way that minimizes the potential growth of undesirable microorganisms. In particular:
  • In the grinder / mixing room we observed the thawed portion of beef used to make their pet food in contact with the concrete floor. As mentioned in violation 2, the floor conditions create possible niches for undesirable microorganisms that can contaminate the thawing material.
  1. They did not take adequate precautions to ensure that their factory operations did not contribute to animal food contamination. In particular:
  • At the cooler, employees are observed to perform sanitation procedures. Excess spray from a pressure washer was seen falling into an open tank of meat that was held for use as pet food.
  • On the killing floor, while employees removed the skin from three cow carcasses, stomach contents and feces were seen decomposing in exposed carcasses. The FDA does not observe these carcasses being rinsed before being put into the cooling area where the carcasses are then separated for pet food use.
  • On the killer floor and in the cooler, carcasses were observed being dragged on the floor, falling from the fence system to the floor and trimmed from the floor in these rooms. As noted in violation 2, the condition of their floors creates a niche for microbial activity that can pollute the carcass.
  1. The company does not maintain a holding and transportation system in a way to protect against animal food contamination. In addition, all plant equipment must be designed from these materials and workmanship so that it can be adequately cleaned and must be properly maintained. In particular:
  • The overhead metal rail used to transport the carcass between the killer floor, the cooling room and the processing room was observed to be poorly maintained. When an overhead rail is being used, paint chipping and product buildup are observed. In addition, this rail is not easy to clean because the paint is peeling / peeling off.
  1. The company does not maintain the physical facilities of their factories in good repair to prevent animal foods from becoming polluted. In particular:
  • On the death floor, worsening and exposed insulation is observed on the ceiling just above where the carcass of the mutilated beef is trimmed and separated for pet food.
  • The cooling unit in the cold room was observed to be in poor repair and dripping condensate directly into the bony open bone footbones, calves, and neck bones used to produce pet food.
  1. Company facilities do not have pipes that are designed, installed and maintained to properly carry waste and liquid waste from the factory and to avoid becoming a source of animal food pollution or creating unclean conditions. In particular:
  • The hand washing sink located on the killer floor and the cooling room does not have adequate pipe connections to prevent water flowing directly to the floor. As mentioned above, carcasses used to produce animal food are dropped, dragged and cut on this floor.

The presence of unwanted microorganisms in their pet food is further evidence of a significant violation of their CGMP.

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

A complete warning letter can be seen here.

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