On July 7, 2007, the Centers for Disease Control and Prevention (“CDC”) learned that two siblings in Texas were critically ill with botulism and that their illnesses were likely acquired by eating contaminated food. Four days later on July 11, public health officials in Indiana reported to the CDC that a married couple in Indiana were suspected of having foodborne botulism. On July 17, CDC staff provided information regarding the production-dates and times to the FDA. The evidence strongly suggested that brands of Castleberry’s hot dog chili sauce were the common source of the four ill persons with botulism. By August 24, eight cases of botulism had been reported to the CDC. In addition to the Indiana couple, the mother of the children in Texas had developed symptoms of botulism, which brought the total number of Castleberry-associated cases in Texas to three. There were also three unrelated residents of Ohio who had developed botulism consuming Castleberry’s hot dog chili sauce in the week before symptom onsets. Botulinum toxin was identified in leftover chili sauce collected from the refrigerator belonging to one of the Ohio cases.
On July 18 and 19, a team of federal investigators were sent to the firm’s warehouse. Samples of Castleberry’s Austex and Castleberry’s brand Hot Dog Chili Sauce with the “best by May 7, 2009” and “best by May 8, 2009” lot codes were collected and sent to FDA laboratories for testing. FDA testing of sample 428113, consisting of 17 swollen cans, found C. Botulinum toxin in 16 of the cans. This sample included the same time-stamp and lot code from the May 8, 2007 production as the can found in the Indiana home. FDA testing of sample 420352, consisting of six swollen cans, found C. Botulinum in four cans. FDA sample 420353 included one swollen can, and its contents tested positive for C. Botulinum toxin.
Federal investigators conducted extensive tests on Castleberry equipment. The findings are presented in an FDA report issued on August 10, 2007. Noted observations include:
1. The system, equipment, and procedures used for thermal processing of foods in hermetically sealed containers were not operated and administered in a manner that ensures commercial sterility is achieved.
2. Each retort did not have an accurate temperature records device.
3. Failure to supply a suitable water valve used for water cooling to prevent leakage of water into the retort during processing.
4. The condensate bleeder was not checked with sufficient frequency to ensure removal of condensate or equipped with an automatic alarm system for the continuous monitoring of condensate bleeder functioning.
5. Required information was not entered on designated forms at the time the observation was made by the retort or processing system operator or designated person.
6. Failure to maintain fixtures in repair sufficient to prevent food from becoming adulterated.
7. Failure to properly adjust the temperature-recording device. The temperature recorded on the temperature-recording device chart was higher than the mercury-in-glass thermometer during processing.
The report ultimately placed blame on Castleberry management saying there was no commitment from employees in making the products and there was not adequate management oversight. As one Castleberry employee noted: “Two years ago the [implicated reports] were maintained very well, but they are maintained poorly now.” The FDA plainly agreed, citing Castleberry’s for the “failure to maintain fixtures in repair sufficient to prevent food from becoming adulterated.” This is the story of one of those cases.