Bush Brothers & Co. in Tennessee is on notice from the FDA because of significant deviations from the Low-Acid Canned Food regulations and insanitary facility conditions.

The violations render the firm’s food products adulterated in that they have been prepared, packed, or held under conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to heath.

Staff from the Food and Drug Administration inspected the Dandridge, TN, location of Bush Brothers & Co. on June 10 through 14. They discovered the “serious violations” regarding the firm’s Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers, according to a Sept. 29 warning letter made public by the FDA in recent days.

Bush Brothers & Co. manufactures a variety of Low-Acid Canned Food (LACF) products including baked beans, black beans, butter beans, navy beans, white beans, pinto beans, and hominy.

“As a manufacturer of LACF products, you are required to comply with the Federal Food, Drug, and Cosmetic Act (the Act) and the federal regulations relating to the processing of LACF products,” according to the letter sent to Joseph C. Breid, Director of Operations for Bush Brothers & Co.

Although the firm responded to the FDA on Aug. 4 with a letter including a narrative description of the corrective actions taken, the FDA noted the following, unresolved, significant violations:

  • First, the firm failed to promptly report to FDA any instance of spoilage or potential public health significance where any such lot of food had in whole or in part entered distribution.

“Specifically, you shipped or allowed to remain in distribution and out of your control, various flavored LACF bean products after a side seam defect was identified on June 7, 2017, by plant personnel.”

The can seam defect was confirmed by the can manufacturer and was identified as a “weld adhesion failure” on the side seams of 28 oz. cans manufactured by the can supplier on various dates.

After further evaluation, more dates were included as cans that had weld adhesion failures, but the firm only considered a market withdrawal for cans manufactured on the marked date with the most can seam defects; “The explanation provided to the FDA Investigators was that your Quality Assurance Department identified this as a food quality issue and not a food safety issue.”

  • Second, the firm did not conduct any microbiological tests on the questionable lots at the time of the inspection, and, was not able to give assurance that those products would pose no significant health risks to consumers due to potential post-process contamination based on the observed side seam defect.

Specifically, “Inadequate or improper manufacturing, processing, or packing of thermally processed low-acid foods in hermetically sealed containers, including partially welded side seams, could foster the growth of microorganisms such as Clostridium botulinum that could potentially cause illness or even fatal food poisoning.”

  • Third, the firm’s cooling water that is held at a constant sanitizer level may eventually exhibit an eventual increase in bacterial populations since the organisms can become acclimated to the sanitizer levels.

Additionally, “Post processing contamination may occur from improper handling of containers on contaminated conveyor belts, runways, container tracks, and in distribution at the retail level.  Any significant abuse of the containers can cause the already present defect to leak contaminated water or air.”

  • Fourth, the firm failed to perform and record defects of containers, and perform a corrective action when cans were identified as losing their hermetic seal.

Furthermore, when FDA investigators collected documentation for results of 28 oz. Brown Sugar Hickory, lot 6097V, the space for the number of rejected cans was left blank, and “Quit Due to Busting Seams” was handwritten on the document, “indicating sorting had ceased due to the failing can vacuum.” However, FDA investigators later determined that cases of this product lot had been shipped into commerce.

  • Fifth, the information that the firm provided in the Aug. 4 response letter states that affected cans were “subjected 100%” to an incubation period, however, product was stored at ambient warehouse temperatures that could have significant fluctuations in temperatures.

According to the warning letter, “Incubation tests are to be conducted at the optimum temperature for bacterial growth and fluctuation in warehouse temperatures do not provide optimum growth conditions for recovery of spoiled product.”

Food companies are given 15 working days to respond to FDA warning letters. “You should take prompt action to correct the violations noted in this letter. Failure to do so may result in regulatory action by FDA without further notice, including, without limitation, seizure and injunction,” according to the warning letter.

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