I love the FDA’s ongoing release of warning letters. This practice gives an insight into what’s happening in food facilities, especially important are the ones that are linked to outbreaks. FDA warning letters and 483 inspection forms have brought gold like us tugging at the dried skin of bearded dragons as well as scratching intergluteal clefts.
As the great Stefon says, the Kerry Inc./Honey Smacks warning letter has everything – pathogens, incomplete hazard analyses and poor sanitation.
Your hazard analysis did not identify a known or reasonably foreseeable hazard for each type of food manufactured, processed, packed, or held at your facility to determine whether there are any hazards requiring a preventive control as required by 21 CFR 117.130(a)(1).
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),
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).