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.
Bravo Packing Inc., Carney’s Point, NJ
Amanda Lloyd, President
In a March 16, 2020, warning letter the FDA described a July 22, 24, and Aug. 6, 2019, an 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 your facility. 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. 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. 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. 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. 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 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 their 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. 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, 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. 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 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.
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 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. 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 thier 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.
Fuji Food Products Inc., Santa Fe Springs, CA
Farrell Hirsch, President and CEO
During an inspection from Nov. 12 through Dec. 4, 2019, FDA staff collected environmental samples from various areas of the company’ processing facility and found the presence of Listeria monocytogenes. In addition, FDA staff found “serious violations” of the seafood “Hazard Analysis and Critical Control Point” (HACCP) regulation.
FDA’s inspection resulted in issuance of an FDA Form 483 Inspectional Observations report listing deviations. The firm responded Dec. 17, 2019, Dec. 26, 2019, Jan. 17, 2020, and Feb. 7, 2020, but the agency’s warning letter says the responses were inadequate.
Based on FDA’s inspectional findings, the agency determined that the company’s ready-to-eat (RTE) sushi rolls and seafood poke bowls are adulterated in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health.
Presence of Listeria monocytogenes:
FDA laboratory analysis of the environmental sample INV1122051 collected on Nov.12, 2019, during the production of RTE sushi rolls, confirmed 32 of (redacted by FDA) environmental swabs collected positive for Listeria monocytogenes. Of the positive findings, 10 swabs were collected from food-contact surfaces which include the cutting beds on your sushi roll cutters; the cutting knives situated below the cutting bed on their sushi roll cutters; the roll portioning/cutting knife that cuts the assembled and formed sushi roll; the hard-white plastic surface that holds the assembled and formed sushi roll; and the white out-feed conveyor belt surfaces. Additionally, 20 swabs were found positive for L. monocytogenes on areas directly adjacent to food contact surfaces in their main processing room.
This was not the first time FDA investigators collected environmental samples from the facility that were found to be positive for L. monocytogenes. An environmental sample collected on Apr. 22, 2019, confirmed 7 of (redacted) swabs collected were positive for L. monocytogenes. Of these positive findings, 5 swabs were collected from food contact surfaces, which included the sushi cutting machines and conveyor belt.
Whole genome sequencing (WGS) was conducted on 32 L. monocytogenes isolates obtained from the FDA environmental sample collected on Nov. 12, 2019, and seven L. monocytogenes isolates obtained from the FDA environmental sample collected on April 22, 2019. The current WGS analysis determined that the isolates derived from the samples collected at their facility during the two inspections referenced above represent a single strain of L. monocytogenes, indicating the presence of a resident pathogen since at least April 2019. FDA advised the company of those WGS results via a conference call on Dec. 12, 2019.
The recurring presence of L. monocytogenes in their facility is significant in that it demonstrates their sanitation efforts are inadequate to effectively control pathogens on their processing equipment and in their facility to prevent contamination of food.
“Our findings indicate that their firm is neither achieving satisfactory control against the presence of L. monocytogenes within their facility nor implementing effective methods and controls to eliminate this human pathogen or minimize exposure to food and food-contact surfaces,” according to the warning letter.
Appropriate control of L. monocytogenes in a food processing environment requires expert knowledge of the unique characteristics of the organism and the corresponding hygienic practices necessary to eliminate this pathogen. Once it is established in a production area, personnel or equipment can facilitate the pathogen’s movement and contamination of food-contact surfaces and finished product. Therefore, it is essential to identify the areas of the food processing plant where this organism is able to grow and survive and to take such corrective actions as necessary to eradicate the organism by rendering these areas unable to support the growth and survival of the organism.
Seafood HACCP significant deviations:
The firm did not monitor the following with sufficient frequency to ensure compliance with the “current good manufacturing practice requirements”: Worn and frayed edges on the sushi manufacturing roll machine (redacted) white conveyor belt used to transfer the ready-to-eat products to an employee for placement on metal trays. Swabs of this conveyor belt were found positive for L. monocytogenes. Cracks and missing pieces were observed on the blue plastic finished product conveyor belt of sushi roll packaging line #1, during the packaging of California Roll with use by date 11/22/19. Prevention of cross-contamination from insanitary objects to food, observations: Apparent over-spray from an employee that was spraying water onto the floor in the “blue room,” a refrigerated product storage area, was observed to saturate the following;
The exterior packaging of RTE ingredients including:
Toasted sesame seed, 80/20 manufacturer lot 200300-TNM-255-19. Fujisan sushi seasoning, production date 8/16/19. Swiss cheese sauce SWCHEESE_NGMO_8, Production date 10/29/19. Non-RTE ingredient, Homai, California brown rice. Cleaning and sanitizing operations were being performed for sushi rolling machines in an area immediately adjacent to the manufacturing, processing and packing of RTE products including shrimp spring roll. There was inadequate separation of sanitation activities from processing activities to prevent cross contamination from aerosolized overspray. Swabs collected from some sushi rolling machines (redacted) were found positive for L. monocytogenes. A trigger style water sprayer used in the cleaning operations of the sushi roll machine was observed between uses being placed on the ground. Additionally, there were multiple layers of white tape and/or plastic around the base of the sprayer. A trigger style water sprayer was observed hanging on a rack partially over a colander that contained multiple processing utensils. The hose attached to the spray handle was partially on the ground. The trigger style sprayer had multiple layers of black tape and/or plastic around the base. Protection of food, food packaging material, and food contact surfaces from adulteration with condensate and plant must be constructed in such a manner that condensate from fixtures, ducts and pipes does not contaminate food, food-contact surfaces, or food-packaging materials. FDA investigators observed: During the manufacturing of spicy surimi mix, a component of your spicy California rolls with use by date 11/22/19, significant condensation was observed accumulating on the bottom of the cooling unit drip pan directly above the processing table, product scale and food contact bin in the prep room. This condensate was observed dripping onto the processing table, product scale and food contact bin. FDA swab # 67 collected from the floor drain near this dripping condensate and the processing table was found positive for L. monocytogenes. Condensation was also accumulating on the drip pan drain pipe in the prep room. This pipe passes directly above the (redacted) used in manufacturing spicy surimi mix that was a component of their spicy California rolls with use by date 11/22/19. FDA swab # 68 from the floor wall junction directly below this condensation accumulation was found positive for L. monocytogenes. Dripping condensate is a repeat observation from FDA’s previous inspection which concluded on Apr. 30, 2019.
The firm’s corrective action responses address the immediate sanitation concerns as well as outlining long term corrective actions that they plan on implementing, including consulting with a third-party expert to assist in assessing how to implement better condensate control within their environment and implementing corrective action measures based on their findings.
In addition to these actions, when processing they must monitor conditions with sufficient frequency to ensure employee practices prevent cross-contamination from insanitary objects, including over-spray and that food, food packaging material, and food contact surfaces are protected from adulteration with condensate. The FDA will verify the adequacy of these corrective actions during their next inspection.
They must have a HACCP plan that, at a minimum, lists the critical limits that must be met. A critical limit is defined as “the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard.” The firm’s HACCP plan for “Fully cooked fresh sushi/ seafood products/ shrimp products” lists critical limits of “Temperature Refrigerated products: (redacted)” and “Refrigerated Shellfish /Fish: (redacted)” at the “Receiving (refrigerate/refrigerated seafood and frozen products)” critical control point that are not adequate by themselves to control the food safety hazard of pathogenic bacteria growth and toxin formation, including Clostridium botulinum (C. botulinum) growth and toxin formation, as a result of time and temperature abuse during transit of refrigerated seafood products. Relying on internal temperatures alone, taken at the time of receipt, does not ensure the products were continuously held under adequate refrigeration temperatures throughout transit to your facility. The FDA recommends their critical limits list that refrigerated seafood is maintained at 40°F or below, or below 38°F for control of nonproteolytic C. botulinum, throughout transit using a continuous temperature recording device. The firm’s HACCP plan for “Fully cooked fresh sushi/ seafood products/ shrimp products” lists critical limits of “All labels should come with correct allergenic profile stated on it as required on the finished product packages. Should be verified with the master label document” at the “Receiving packing and labels” critical control point that is not adequate by itself to control the food safety hazard of undeclared major food allergens. Specifically, during their inspection we found your firm manufactures seafood products that contain one or more of the major food allergens including crustacean shellfish (e.g., crab or shrimp), Eggs, Fish (e.g., finfish in surimi, salmon, anchovies), Soy, and Wheat. The critical limits in your HACCP plan do not ensure that finished products are properly labeled. The FDA recommends that their critical limit also ensure the finished products are appropriately labeled with the correct allergen declarations.
The full warning letter can be viewed here.
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