I took the time to fully read FDA Warning Letter sent to Kerry, Inc., that manufactured Honey Smacks for Kellogg’s. Here is the somewhat redacted beginning:
The United States Food & Drug Administration (FDA) inspected your Kerry, Inc. facility, located at 320 West Gridley Road, Gridley, IL 61744-8723 from June 14 to 29, 2018. The inspection was initiated as (b)(4) in three environmental swabs taken from your (b)(4) cereal (“cereal”) production rooms during FDA’s inspection. Further, FDA’s Whole Genome Sequencing (WGS) analysis of the three isolates of (b)(4).
Here are the highlights/lowlights of the Warning Letter:
Between September 29, 2016 and May 16, 2018, you repeatedly found Salmonella throughout your facility, including in cereal production rooms. During this time period, you had 81 positive Salmonella environmental samples and 32 positive Salmonella vector samples (samples taken in response to finding a positive on routine testing), including four Salmonella (b)(4) samples in the cereal coating room (Line (b)(4)) and one Salmonella (b)(4) sample in the cereal (b)(4) room (Line (b)(4)). Further, you had repeated findings of other Salmonella species in some production lines and rooms used for the manufacture of cereal. These repeated findings of Salmonella in your environment should have resulted in a reanalysis of your food safety plan as required by 21 CFR § 117.170(b)(4) and the identification of contamination of RTE cereal with environmental pathogens as a hazard requiring a preventive control (i.e., sanitation preventive control).
So, in the coming days, as I explain to clients how a company, like Kerry, can seem to ignore 113 positive Salmonella samples and continue to manufacture and ship the Sugar Smacks. The Kerry, the FDA and Kellogg’s will need to explain this to the general public. My clients and a part of the public is included in:
Total Salmonella Illnesses: 135
Last illness onset: 8/29/2018