Bravo Packing Inc. received FDA warning letter nearly one year before latest recall
On March 3, Bravo Packing Inc. of Carneys Point, NJ, recalled all of its raw frozen pet food — ground beef and “Performance Dog” — after tests showed contamination with Salmonella and Listeria monocytogenes.
Consumers should take extra care if they have any recalled dog food in their homes because there is a danger to human health if people fail to follow proper handwashing and sanitization procedures, according to the company recall notice posted by the Food and Drug Administration.
This recall resembles a recall from Sept. 2018 of all of the company’s Performance Dog frozen raw pet food products because of potential Salmonella contamination. That recall prompted a facility inspection in 2019 and in March 2020 Bravo Packing Inc. received a warning letter from the Food and Drug Administration detailing violations at the facility.
The full warning letter issued one year ago was part of standard enforcement activities. See excerpts below.
Some FDA warning 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. The FDA frequently redacts parts of warning letters posted for public view.
Bravo Packing Inc.
Carney’s Point, NJ
A food firm in Jersey is on notice from the FDA for violations of the Federal Food, Drug, and Cosmetic Act at their facility. The FDA states in the letter that the firm manufactures raw pet food in ways in which the pet food could become contaminated by undesirable microorganisms for which the firm has no control step.
In a March 16, 2020, warning letter the FDA described a July 22, 24, and Aug. 6, 2019, inspection at Bravo Packing Inc. in Carney’s Point, NJ. Inspectors found serious violations of the Federal Food, Drug, and Cosmetic Act.
The inspection was a follow-up to assess any corrections made since the company’s Class I recall of its Performance Dog Food after an FDA sample taken during a 2018 inspection revealed the presence of Salmonella.
FDA’s inspection resulted in issuance of an FDA Form 483 Inspectional Observations report listing deviations.
FDA inspection of the plant, including their manufacturing process, revealed several violations:
- They did not keep animal food-contact and non-contact surfaces of utensils and equipment cleaned and maintained as necessary to protect against contamination of animal food and animal food-contact surfaces. In addition, in wet processing of animal food, when cleaning and sanitizing are necessary to protect against the introduction of undesirable microorganisms into animal food, all animal food-contact surfaces must be cleaned and sanitized before use.
Investigators observing their sanitation operations documented that dried food residue was left on equipment used to manufacture raw, frozen, ready-to-eat dog food, despite the equipment being identified as “clean” by an employee.
Additionally, their sanitation procedures comprised just high-pressure hot water rinsing, spraying with undiluted bleach, and a final rinse. They do not use detergent, manual scrubbing, or other appropriate procedures to remove meat and fat residue from food-contact surfaces in their facility. Below are several specific observations noted by FDA investigators during the 2019 inspection:
- On July 22, 2019, the exiting end of the auger that feeds the raw ingredient beef into the mixer was observed to have heavy buildup of dried, dark, crusty meat-like material. A film residue was also observed on the sides of the exit chute.
- On July 24, 2019, FDA investigators observed a greasy buildup of animal fat where the grinder feeds into the auger. This was observed after the machine had been cleaned, prior to the bleach spray step.
- On July 24, 2019, the buckets that are used to hold cut meat exhibited a black residue on the inside surface. They stated these buckets had been cleaned.
2. They did not use toxic materials, such as cleaning compounds and sanitizing agents, in a manner that protects animal food, animal food-contact surfaces or animal food-packaging materials from contamination.
- On July 24, 2019, the buckets mentioned above, used to hold cut meat, were also observed to contain what appeared to be pooled sanitizer in the bottom of the buckets.
- When animal food-contact surfaces are wet-cleaned, it may be necessary to thoroughly dry these surfaces before they are used again, as well.
3. They did not hold animal food for distribution under conditions that protect against contamination and minimize deterioration.
- On July 22 and July 24, 2019, condensate drip, pools of water on the floor, and ice buildup on several boxes of finished raw dog food products were observed in one of their firm’s freezers. These are indications that the freezer is not functioning properly. Further, numerous boxes were not sealed closed and FDA investigators observed one open box with damaged packaging, in which the finished product was being contaminated by condensate drip.
4. They did not take effective measures to exclude pests from the packing area and to protect against the contamination of animal food by pests.
- On July 24, 2019, FDA investigators observed pallets of cardboard boxes stored in a three-sided covered garage. The boxes, used to pack finished product, such as the boxed product stored in their freezer, were observed to have avian droppings on the top, sides, and along the bottom of numerous pallets. Apparent mammalian excreta was observed adjacent to the palletized boxes located along the back wall of the garage. This practice of storing their unprotected packing material under birds and among excreta creates a pathway for contaminating their finished product with animal and bird fecal matter and the pathogens such matter may contain.
5. Each individual engaged in manufacturing, processing, packing, or holding animal food must have the education, training or experience (or a combination thereof) necessary to manufacture, process, pack, or hold safe animal food as appropriate to the individual’s assigned duties and have received training in the principles of animal food hygiene and animal food safety. Records documenting the training in the principles of animal food hygiene and animal food safety must be established and maintained.
- On July 24, 2019, while observing employee cleaning practices, FDA investigator noted that it appeared that the employee had not been trained on how to properly remove remnants and residue of meat products remaining on the machine after processing. They stated that employees have not been instructed to scrape any portion of the production machinery. The employee also was not instructed or trained to use a degreaser for the removal of residue on the sides of the auger, and on July 22, 2019, the employee stated that he used undiluted bleach on the processing equipment, instead of diluting the bleach properly for use as a sanitizer.
- FDA investigators observed that their firm did not maintain training records and was not able to provide documentation that the employees working in direct contact with the raw dog food product had been trained in principles of animal food safety or animal food hygiene.
The firm manufactures raw pet food and the practices described above are ways in which the pet food manufacture could become contaminated by undesirable microorganisms for which they have no control step. Undesirable microorganisms include microorganisms that are pathogens, that subject animal food to decomposition, that indicate that animal food is contaminated with filth, or that otherwise may cause animal food to be adulterated. Pet owners and other people can become ill from pathogens in pet food by handling the food or coming into contact with surfaces of utensils used for the food.
The presence of undesirable microorganisms in pet food is evidence of the significance of the CGMP violations. On July 24, 2019, FDA Investigators collected samples of two of their finished dog food products and FDA laboratory analysis found Salmonella and Listeria monocytogenes, both of which are undesirable microorganisms. “Performance Dog Food” was found to contain Listeria monocytogenes and Salmonella, and “Beef Dog Food” was found to contain Salmonella.
The full warning letter can be viewed here.
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