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Bush Brothers & Company MARCS-CMS 535494 —

Delivery Method:

Recipient Name
Joseph C. Breid
Bush Brothers & Company

3304 Chestnut Hill Road
Dandridge, TN 37725-7224
United States

Issuing Office:
Cincinnati District Office

United States



Black HHS-Blue FDA Logo



Cincinnati District Office
6751 Steger Drive
Cincinnati, OH 45237
Telephone: (513) 679-2700
FAX: (513) 679-2772


September 29, 2017
Warning letter 535494
Delivery Signature Requested
Joseph C. Breid, Director of Operations
Bush Brothers & Company
3304 Chestnut Hill Road
Dandridge, Tennessee 37725-7224
Dear Mr. Breid:
On July 10-14, 2017, United States Food and Drug Administration (FDA) inspected your low-acid canned food (LACF) manufacturing facility, located at 3304 Chestnut Hill Road, Dandridge, Tennessee. This inspection found your firm manufactures a variety of LACF products including, but not limited to, baked beans, black beans, butter beans, navy beans, white beans, pinto beans, and hominy. The inspection determined you have significant deviations from the Low-Acid Canned Foods (LACF) regulations, Title 21, Code of Federal Regulations, Part 108, Emergency Permit Control (21 CFR 108), and Part 113, Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers (21 CFR 113). 
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. These regulations are described in 21 CFR 108, Emergency Permit Control, and 21 CFR 113, Thermally Processed LACF Packaged in Hermetically Sealed Containers. The Emergency Permit Control regulations were issued, in part, pursuant to Section 404 of the Act, Emergency Permit Control [21 United States Code (USC) 344].  A temporary emergency permit may be required for LACF products whenever a processor has failed to fulfill the requirements of 21 CFR 108.35, including registration and filing of process information, and the mandatory requirements in 21 CFR 113.
In addition, based upon certain criteria in 21 CFR 113, low-acid foods may be adulterated within the meaning of Section 402(a)(4), [21 USC 342(a)(4)] because they have been prepared, packed, or held under insanitary conditions whereby they have become contaminated with filth, or whereby they may have been rendered injurious to health.  You can find the Act and the LACF regulations through links on FDA’s Internet home page at www.fda.gov.
We acknowledge receipt of your firm’s response to the form FDA 483 (FDA 483) provided August 4, 2017.  The violations found during the inspection coupled with our evaluation of each of your responses are discussed below as follows:
1.    You 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, as required by 21 CFR 108.35(d).
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 5/29, 5/30, 5/31, 6/1, and 6/2/2017.  After more evaluation, the dates of 6/3, 6/4, 6/5, and 6/6/17, were also included as cans that had weld adhesion failures.  However, after questioning by FDA Investigators, you only considered a market withdrawal for cans manufactured on 5/31/17, as that date was identified as having 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.
The quantity and identification of products packed in the aforementioned can manufacturing dates, and which were no longer in your firm's control are identified with the bullets below:
  • (b)(4) cases (12 cans per case) of Original Baked Beans manufactured on 6/5/17
  • (b)(4) cases (12 cans per case) of Country Style Baked Beans manufactured on 6/7/17
  • (b)(4) cases (12 cans per case) of Country Style Baked Beans manufactured on 6/8/17
  • (b)(4) cases (12 cans per case) of Brown Sugar Hickory Baked Beans manufactured on 6/9/17 
Additionally, your 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.
We acknowledge that your firm initiated a voluntary recall of affected product on July 21, 2017, and conducted an evaluation of the product that was placed on hold after the recall.  We also acknowledge that your August 4, 2017, response to the FDA 483 indicated using alternative sources of cans once the faulty side seams were detected.
We note that hermetically sealed containers, as defined by 21 CFR 113.3(j), are containers designed and intended to be secure against the entry of microorganisms and thereby to maintain the commercial sterility of its contents after processing. Seam and seal evaluations cannot be relied on as an indicator of good hermetic seals when gross container defects, such as partially welded side seams, are present and cannot completely be detected by physical examination.  These defects differ from the normal seaming defects such as out of tolerance values for overlap, looseness and sharp seams. In addition, this type of defect does not always produce a definitive loss of vacuum.  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. 

Your firm’s August 4th response also addressed the microbiological quality of the cooling water in the (b)(4) in that it could not be a potential source for post-process contamination.  Although not required by 21 CFR 113, our inspection revealed that your firm does not routinely check for Total Plate Count (TPC) of the (b)(4) water, and it is only monitored (b)(4).  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.
2.    Your firm failed to perform and record defects of containers, and perform a corrective action when cans were identified as losing their hermetic seal, as required by 21 CFR 113.60(a)(1). 
Specifically, the inspection conducted on July 7-14, 2017, revealed a practice of concern performed by your firm.  The inspection revealed your firm sorted cans through a (b)(4) device used to identify cans that have lost vacuum.  Reportedly, if cans passed the (b)(4) device tests, after they have been held and multiple sorts have been performed, your firm released the remaining cans for distribution.  The “(b)(4) records designate whether the problem is a “(b)(4)”, or a “(b)(4)”.  Each of the “(b)(4)” records associated with the can seam defects due to the weld adhesion failure identified by the plant and the can manufacturer, identify the problem as a “(b)(4)”.  The description of the deviation is described as “Bad Side Seam.”
Furthermore, the “(b)(4)” records identified below are incomplete in that they do not document how many cans were rejected by the (b)(4) device, a method in which your firm uses to measure can vacuum and whether or not the can is acceptable for release:
  • 6057 (b)(4) 
  • 6087 (b)(4) 
  • 6097 (b)(4) 
Based on our inspection, the utilization of proximity technology appears to be a standard practice for your firm.  Accordingly, our investigators collected documentation for the (b)(4) device results for 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.  Later, it was determined (b)(4) cases of this lot had been shipped into commerce.
In general, (b)(4) does not adequately address the evaluation of cans which have been, or may have been, compromised.  Container vacuum, and consequently lid deflection, is dependent on several factors, none of which are consistently 100% accurate as there will always be a noticeable difference in vacuum or negative pressure in the container and consequently a variation in lid defection.  In addition, your firm did not provide specific parameters applied to the pass/fail conditions used with the lid deflection analysis (i.e. what degree of deflection constitutes a rejected container).  Consequently, the use of a (b)(4) device or any other device that measures lid deflection is not a definitive procedure for evaluating containers.
Your firm’s August 4, 2017, response to the FDA 483 also indicated you subjected 100% of the affected cans to an incubation period; however, the information provided states that the product was stored at ambient warehouse temperatures (b)(4), which could have significant fluctuations in temperatures. 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.
This letter is not intended to be an all-inclusive list of deficiencies in your plant. It is your responsibility to ensure all of your products comply with the Act, the low-acid canned food regulations (21 CFR 108 and 113), and the Current Good Manufacturing Practice regulations (21 CFR 110), and other applicable regulations.  The specific violations noted in this letter and in the FDA 483, issued at the close out of the inspection, may be symptomatic of serious problems in your firm's manufacturing and quality assurance systems.  You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your product into compliance.
You should take prompt action to correct the violations cited in this letter.  Failure to promptly correct these violations may result in FDA taking regulatory action without further notice, such as seizure or injunction.
You should respond in writing within 15 working days from the date you receive this letter. Your response should include specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken.  If your planned correction will occur over time, please include a timetable for implementation of those corrections.  If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed. Your response should be comprehensive and address all violations included in this Warning Letter.
Section 743 of the Act (21 USC 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees [21 USC 379j-31(a)(2)(B)]. FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection related costs.
Your response should be sent to:  Ms. Kimberly Dutzek, Compliance Officer, U.S. Food and Drug Administration, 404 BNA Drive, Suite 500, Nashville, TN 37217.  If you have any questions about the content of this letter please contact Ms. Dutzek at (615) 366-7826.
Steven B. Barber
Director, Division V
Office of Human and Animal Foods Operations-East
cc:   Timothy A. Haley, Director, Regulatory Affairs
       Bush Brothers and Company
       1016 East Weisgarber Road
        Knoxville, TN 37909-2669


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