Bush Beans was issued a warning letter related to how they handled a can seam issue this past summer. Although a
recall was conducted, FDA cited the plant for not notifying FDA of the issue, minimizing the issue even though a container failure issue could be danger to the public, and failing to take appropriate action regarding in-process rejects. The issue was that the firm did not take appropriate action to a supplier related can seam issue. Can seam issues for low acid canned foods can result in serious issues such as the potential for Clostridium botulinum.
The warning letter specified two major items:
1. 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, by distributing bean products after a side seam defect was identified by plant personnel and confirmed by the can manufacturer. The issue was identified as a weld adhesion failure on the side seams. The company only considered a market withdrawal for cans manufactured on one day identified as having the most can seam defects, but other dates were involved. "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." Additionally, 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. The firm did not routinely do microbiological analysis of the cooling water, which while not expressly required, it is important to show control.
2. Failed to perform and record defects of containers, and perform a corrective action when cans were identified as losing their hermetic seal. Basically, the firm had an inline dud detector to determine which cans had lost vacuum, but the record keeping was poor and there was no follow-up to cans that were rejected.
The Low Acid Canned Food regulations (LACF) are in place for all those who package low acid canned foods where Clostridium botulinum can be an issue.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm578558.htm
September 29, 2017
Warning letter 535494