This Warning letter was issued from the FDA on March 16, 2020 to Bravo Packing (this is not the same as Bravo Pet Foods). On September 26, 2019, the FDA cautioned pet owners not to feed their pets any Performance Dog frozen raw pet food after a sample tested positive for Salmonella and Listeria monocytogenes (L. mono). You can read the caution here.
March 16, 2020 (read entire warning letter here)
Dear Ms. Lloyd & Mr. Merola:
On July 22, July 24, and August 6, 2019, the U.S. Food and Drug Administration (FDA or “we”) conducted an inspection of your facility located at 59 N. Golfwood Avenue, Carneys Point, New Jersey, 08069. This inspection was a compliance follow-up inspection to assess any corrections made since your Class I recall of your Performance Dog Food after an FDA sample taken during a 2018 inspection revealed the presence of Salmonella. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that we found during our inspection of your operation.
At the close of the inspection, you were issued a Form FDA 483, Inspectional Observations. Although you have not submitted a written response to the Form FDA 483 explaining what you have done to address our observations, we note that you made some corrections prior to the close of the inspection, and we address those corrections below. We encourage you to respond in writing to this letter.
Our inspection found significant violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals (PCAF) regulation, Title 21, Code of Federal Regulations, Part 507 (21 CFR Part 507). As a result of these violations, the raw pet foods manufactured in your facility are adulterated in that they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health.1 Further, the introduction or delivery for introduction into interstate commerce of an adulterated food is a prohibited act.2 You may find the FD&C Act and FDA’s regulations through links on FDA’s homepage at www.fda.gov.
Current Good Manufacturing Practice (CGMP) Requirement Violations
Our inspection of your plant, including your manufacturing process, revealed several violations of the 21 CFR part 507 CGMP regulation. Specifically:
1. You 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. [21 CFR 507.19(b)(2)].
Investigators observing your 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, your sanitation procedures comprised just high-pressure hot water rinsing, spraying with undiluted bleach, and a final rinse. You do not use detergent, manual scrubbing, or other appropriate procedures to remove meat and fat residue from food-contact surfaces in your facility, despite this item being discussed with you during and after our 2018 inspection. Below are several specific observations noted by our 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. According to you, the equipment had been cleaned prior to the start of the inspection. On 7/24/2019, after cleaning had been completed, the elbow portion of the feeder pipe from the mixer to the stuffer hopper had a buildup of dried, dark, crusty meat-like material. The meat-like material had not been removed during the cleaning process, making the cleaning ineffective.
• On July 24, 2019, our 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. You stated these buckets had been cleaned.
2. You 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. [21 CFR 507.19(d)(2)].
• 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. [21 CFR 507.19(b)(1)].
3. You did not hold animal food for distribution under conditions that protect against contamination and minimize deterioration. [21 CFR 507.27(a)].
• 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 your firm's freezers. These are indications that the freezer is not functioning properly. Further, numerous boxes were not sealed closed and our investigators observed one open box with damaged packaging, in which the finished product was being contaminated by condensate drip.
4. You did not take effective measures to exclude pests from the packing area and to protect against the contamination of animal food by pests. [21 CFR 507.19(e)].
• On July 24, 2019, our 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 your 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 your unprotected packing material under birds and among excreta creates a pathway for contaminating your finished product with animal and bird fecal matter and the pathogens such matter may contain.
5. You did not ensure that all individuals who manufacture, process, pack, or hold animal food subject to the 21 CFR part 507 CGMPs are qualified to perform their assigned duties. [21 CFR 507.4(a)(1)]. 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. [21 CFR 507.4(b)]. Records documenting the training in the principles of animal food hygiene and animal food safety must be established and maintained. [21 CFR 507.4(d)].
• On July 24, 2019, while observing employee cleaning practices, our 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. You 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.
• Our investigator observed that your 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.
Your firm manufactures raw pet food and the practices described above are ways in which the pet food you manufacture could become contaminated by undesirable microorganisms for which you 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. (21 CFR 507.3).
The presence of undesirable microorganisms in your pet food is further evidence of the significance of your CGMP violations. On July 24, 2019, FDA Investigators collected samples of two of your finished dog food products and FDA laboratory analysis found Salmonella and Listeria monocytogenes, both of which are undesirable microorganisms. “Performance Dog Food” (sample 1109036) was found to contain Listeria monocytogenes and Salmonella, and “Beef Dog Food” (sample 1109037) was found to contain Salmonella.
We acknowledge that some voluntary corrections were made prior to the closeout of our inspection. For example, on July 24, 2019 our investigators noted that the dried meat-like material that had previously been observed on the auger was no longer present, and the employee was using diluted bleach when cleaning the processing equipment. These are both improvements from what was observed on July 22, 2019. Our investigators also noted that the walls in the dog food production room had been cleaned.
We also acknowledge that after our Compliance Officer provided you with test results from the dog food samples on August 26, 2019, you stated that you would voluntarily recall the Performance Dog Food product. (You stated that the Beef Dog Food was not distributed.) However, you did not provide our Compliance Officer with the requested draft customer notification letter, distribution list, and draft press release, so that we could review and advise on the recall strategy (21 CFR 7.42), despite repeated requests on August 26 and 27, 2019 and September 11 and 16, 2019. You stated you did not know where the affected product was distributed. Therefore, FDA issued a consumer advisory on September 26, 2019: https://www.fda.gov/animal-veterinary/news-events/fda-cautions-pet-owners-not-feed-performance-dog-raw-pet-food-due-salmonella-listeria-monocytogenes. This is similar to our experience with your Class I recall of Performance Dog Food due to Salmonella in 2018. During that recall you did not provide the FDA with requested distribution information, nor did you conduct the requested effectiveness checks to assess the depth of the recall.
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence, or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law and FDA regulations.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.
In addition to the above violations, we also have the following comments:
Previous Instance of Undesirable Microorganisms
Undesirable microorganisms have previously been found in your finished raw pet food products, indicating an on-going problem. During a previous inspection of your facility on July 18, 2018, FDA collected a sample of “Performance Dog Food” (sample 1013202) and found Salmonella, leading to a recall.
Current Good Manufacturing Practice and Preventive Controls Requirements
At the conclusion of the 2018 inspection, we provided you with a copy of FDA’s Guidance for Industry #235, Current Good Manufacturing Practice Requirements for Food for Animals, to help you understand the CGMP requirements (including those cited above as inspectional findings at your facility). For example, as managers of your establishment, you must ensure that adequate precautions are taken so that plant operations do not contribute to contamination of animal food, animal food-contact surfaces, and animal food-packaging materials. [21 CFR 507.25(a)(5)]. You also must ensure that all animal food manufacturing, processing, packing, and holding is conducted under such conditions and controls as are necessary to minimize the potential for the growth of undesirable microorganisms to protect against the contamination of animal food. [21 CFR 507.25(a)(8)].
Furthermore, in addition to the sanitation requirements specifically discussed above, the sanitation section of the regulation (21 CFR 507.19) contains other sanitation requirements with which you must comply, as well.
Although not covered during this inspection, you are required to comply with the hazard analysis and risk-based preventive controls requirements found in 21 CFR part 507, subparts C and E, unless an exemption in 21 CFR 507.5 applies.
There is an exemption for qualified facilities, including very small businesses, in 21 CFR 507.5(d). For more information about FDA’s current thinking about this exemption and the requirements that apply to qualified facilities, see FDA’s guidance, Determination of Status as a Qualified Facility Under Part 117: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food and Part 507: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals, available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents.
After the inspection, you mentioned to our Compliance Officer that you are considering the use of peracetic acid and bacteriophages to reduce pathogens in your pet food products. Any substances you use that may become part of your pet food, such as bacteriophages and peracetic acid, must be used as described in an animal food additive regulation, or be generally recognized as safe (GRAS, as defined by the Federal Food, Drug, and Cosmetic Act) for the intended use.
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen (15) working days, state the reason for the delay and the time within which you will complete the correction. If you do not believe that your products are in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.
Section 743 of the FD&C Act [21 U.S.C. § 379j-31] authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including reinspection-related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified non-compliance materially related to a food safety requirement of the FD&C Act, specifically to determine whether compliance has been achieved. Reinspection-related costs means all expenses, including administrative expenses incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees [21 U.S.C. § 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for reinspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified non-compliance materially related to a food safety requirement of the FD&C Act. Accordingly, FDA may assess fees to cover any reinspection-related costs.
Your written response should be sent to the attention of Jessica D. Weber, Compliance Officer at U.S. Food and Drug Administration, 6000 Metro Drive, Suite 101, Baltimore, Maryland 21215. If you have questions regarding this letter, please contact Compliance Officer Jessica Weber at (410) 779-5407.
Randy F. Pack
Acting District Director
Acting Program Division Director
Enjoy your day!
Lisa and Rich Jelinek