FDA WARNING_LETTER - Bush Brothers & Company - July 14, 2017

The FDA inspected Bush Brothers & Company's low-acid canned food (LACF) manufacturing facility in Dandridge, Tennessee, from July 10-14, 2017, identifying significant deviations from 21 CFR 108 and 21 CFR 113 regulations. The firm manufactures various LACF bean products. Two primary violations were cited. First, the firm failed to promptly report instances of spoilage or potential public health significance for distributed food lots, as required by 21 CFR 108.35(d). This stemmed from shipping flavored LACF bean products with identified side seam weld adhesion failures in June 2017. The firm's Quality Assurance Department initially deemed it a quality, not safety, issue, and a voluntary recall was only initiated on July 21, 2017, after FDA inquiry. Microbiological tests were not conducted on questionable lots. Second, the firm failed to perform and record container defects and implement corrective actions when cans lost their hermetic seal, violating 21 CFR 113.60(a)(1). The inspection revealed the firm sorted cans using a vacuum-loss device, but records were incomplete, and the device's reliability for evaluating compromised hermetic seals was questioned. Incubation tests were conducted at ambient warehouse temperatures, not optimal for bacterial growth. These issues indicate serious problems in the firm's manufacturing and quality assurance systems. Bush Brothers & Company must respond within 15 working days, detailing specific corrective actions, prevention plans, and a timetable for completion, to avoid further regulatory action, including potential re-inspection fees.