Bravo Packing Inc. received a warning letter from the FDA almost a year before the last recall
On March 3, Bravo Packing Inc. of Carneys Point, NJ recalled all of its raw frozen pet foods – ground beef and “Performance Dog” – after tests showed contamination with Salmonella and Listeria monocytogenes.
Consumers should be very careful if they have recalled dog food in their home, as there is a danger to human health if people do not follow proper hand washing and sanitizing procedures, according to the advice of Company recall issued by the Food and Drug Administration.
This reminder looks like a reminder from September 2018 of all of the Company’s Raw Frozen Performance Dog pet food products due to potential Salmonella contamination. This recall caused a inspection of facilities in 2019 and March 2020 Bravo Packing Inc. has received a warning letter from the Food and Drug Administration detailing the violations to the facility.
The full warning letter issued a year ago was part of regular enforcement activities. See excerpts below.
Some FDA warning letters are not released to the public until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters are often not issued until a business has had months, if not years, to correct the problems. The FDA frequently writes portions of warning letters that are available to the public.
Bravo Packaging Inc.
Carney Point, NJ
A Jersey food company is notified by the FDA for violating the Federal Food, Drug and Cosmetic Act at their establishment. The FDA states in the letter that the company manufactures raw pet food in such a way that the pet food can be contaminated with unwanted microorganisms for which the company has no control step.
In a March 16, 2020 warning letter, the FDA described an inspection on July 22, 24, and August 6, 2019 at Bravo Packing Inc. in Carney’s Point, NJ. The inspectors found serious violations of federal law on food, drugs and cosmetics.
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.
The FDA inspection resulted in the issuance of an FDA Form 483 Inspection Observation Report listing the deviations.
Inspection of the plant by the FDA, including their manufacturing process, revealed several violations:
- They did not keep feed contact surfaces and non-contact surfaces of utensils and equipment cleaned and maintained as needed to protect against contamination of feed and feed contact surfaces . In addition, in the wet processing of animal feed, where cleaning and disinfection is necessary to protect against the introduction of unwanted microorganisms into the feed, all surfaces in contact with the feed should be cleaned and disinfected before use.
Investigators who observed their sanitation operations documented that dried food residue was left on the equipment used to make raw, frozen and ready-to-eat dog food, although the equipment was identified as “Clean” by an employee.
In addition, their sanitation procedures simply included a high pressure hot water rinse, a spray of undiluted bleach, and a final rinse. They do not use detergent, manual scrubbing, or other proper procedures to remove meat and grease residue from food contact surfaces in their establishment. Here are some specific observations noted by FDA investigators during the 2019 inspection:
- On July 22, 2019, the output end of the auger that feeds raw beef into the mixer was observed to have a heavy build-up of dried meat-like material, dark and crisp. Film residue was also observed on the sides of the exit chute.
- On July 24, 2019, FDA investigators observed a fatty buildup of animal fat where the crusher feeds on the auger. This was observed after cleaning the machine, before the bleach spraying step.
- On July 24, 2019, the buckets used to hold the cut meat had a black residue on the inside surface. They said these buckets had been cleaned.
2. They have not used toxic materials, such as cleaning agents and disinfectants, in a manner that protects animal feed, feed contact surfaces or packaging materials. feed contamination.
- On July 24, 2019, the above-mentioned buckets, used to hold cut meat, were also observed to contain what appeared to be a disinfectant pooled in the bottom of the buckets.
- When surfaces in contact with feed are cleaned with water, it may be necessary to dry these surfaces completely before using them again.
3. They did not hold feed for distribution under conditions that protect against contamination and minimize spoilage.
- On July 22 and 24, 2019, drops of condensate, puddles of water on the floor and an accumulation of ice on several boxes of finished raw dog food products were observed in one of their company’s freezers. These are indications that the freezer is not working properly. Additionally, many boxes were unsealed, and FDA investigators observed an open box with damaged packaging, in which the finished product was contaminated with dripping condensate.
4. They have not taken effective measures to exclude pests from the packing area and to protect against contamination of feed by pests.
- On July 24, 2019, FDA investigators observed pallets of cardboard boxes stored in a three-sided covered garage. The boxes, used to package the finished product, like the canned product stored in their freezer, were observed to contain bird droppings on the top, sides and along the bottom of many pallets. Apparent mammal droppings were observed next to the palletized crates located along the back wall of the garage. This practice of storing their unprotected packaging material under birds and among the droppings creates a pathway to contaminate their finished product with animal and bird faeces and the pathogens these materials may contain.
5. Each person engaged in the manufacture, processing, packaging or keeping of animal feed must have the education, training or experience (or a combination thereof) necessary to manufacture, process, package or keep safe animal feed according to assigned tasks. and have received training in the principles of animal food hygiene and feed safety. Records documenting training in animal food hygiene and animal food safety principles must be established and kept up to date.
- On July 24, 2019, while observing employee cleaning practices, the FDA investigator noted that it appeared the employee had not been trained on how to properly dispose of leftover and residue from meat products remaining on the machine after processing. They said employees were not instructed to scrape any part of the production machinery. The employee was also not given instructions or training to use a degreaser to remove residue from the sides of the auger and on July 22, 2019, the employee said he was using water undiluted bleach on processing equipment, instead of diluting bleach properly. to be used as a disinfectant.
- FDA investigators observed that their company did not keep training records and was unable to provide documentation indicating that employees working in direct contact with the raw dog food product had been trained in the principles of the feed safety or feed hygiene.
The company manufactures raw pet food and the practices described above are ways in which the manufacturing of pet food could become contaminated with unwanted microorganisms for which it has no control. control step. Unwanted microorganisms include microorganisms which are pathogens, which subject feeds to decomposition, which indicate that feed is contaminated with dirt, or which may otherwise cause adulteration of feed. . Pet owners and others can become ill from pathogens in feed when handling food or coming in contact with the surfaces of utensils used for food.
The presence of unwanted microorganisms in pet food is evidence of the significance of CGMP violations. On July 24, 2019, FDA investigators took samples from two of their finished dog food products and FDA lab analysis revealed Salmonella and Listeria monocytogenes, both of which are unwanted microorganisms. “Performance dog food” was found to contain Listeria monocytogenes and Salmonella, and “beef dog food” to contain Salmonella.
The full warning letter can be viewed here.
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