Boulder, Colorado is often called “25 square miles surrounded by reality”.
It’s a place where you’d expect to find a woman-owned organic business like Simplydelicious LLC, maker of Bobo’s Oat Cakes, getting positive reviews for being a “natural start-up.” So taken with Bobo’s, the Boulder Innovation Center’s Natural and Organic program made the business a special project.
Now reality has caught up with Bobo’s Oat Bars, which are popular with outdoors and fitness enthusiasts. Words used to describe manufacturing practices include “rodent excreta” and “urine stains.” Its ingredients and finished food products are “adulterated,” which is government speak for impure.
Further, Simplydelicious LLC also had a poor record at its previous location with pest control problems identified as an issue in four previous inspections by both the U.S. Food and Drug Administration (FDA) and the Colorado Department of Public Health and Environment (CDPHE).
FDA sent Simplydelicious owner Beryl Stafford a “Warning Letter” about the problems on March 23. In the letter, H. Thomas Warwick, Jr., FDA’s Denver district director, informed Stafford about six significant violations. Included were:
1. Failure to take effective measures to exclude pests from the processing areas and protect against the contamination of food on the premises by pests as required by 21 CFR § 110.35(c). During the December inspection the investigator observed the following:
A live rodent was observed in the production area of the bake room beneath a storage rack containing raw materials and utensils.
Approximately twenty-one rodent excreta pellets were observed in the production bake room on a wooden pallet directly below a torn 50 lb. bag of oats, amongst the spillage
Urine stains and seven rodent excreta pellets were observed between two 50 lb. bags of sucanat stored in the warehouse area.
A two-inch by five inch by six-inch deep hole was observed along the floor and wall juncture near the northwest corner of the warehouse. Nesting material and two rodent excreta pellets were observed in this hole.
In addition, numerous rodent excreta pellets were observed in several other locations in your warehouse and gaps were observed under doors with access to production and warehouse areas…
2. Failure to properly store equipment and remove litter and waste from the grounds about the plant as required by 21 CFR 110.20(a)(1). Accumulated unused equipment was observed outside of the building, along both sides of the receiving dock door.
3. Failure to use equipment and/or utensils of an appropriate design to preclude the adulteration of food with metal fragments and contaminants as required by 21 CFR 110.40(a). Specifically:
An employee was observed using a construction-type cordless drill with a painted metal mixing paddle for mixing liquid oat bar ingredients. The paint was observed to be chipped in several places on the mixing paddle and the mixing paddle was not constructed of food grade material.
An employee was observed using a hand-made plastic spatula-type utensil with two exposed screw heads to flatten in-process oat bar dough into pans. The screw heads came in direct contact with product and were not removable for cleaning. Plastic molding on this utensil was cracked and the edges were split.
Failure to maintain all equipment and utensils in an acceptable condition through appropriate cleaning and sanitizing as required by 21 CFR 110.80(b)(1). Specifically, soap was not observed to be used in the process of cleaning pots/pans, utensils, or other equipment utilized in the production of allergen (peanut butter) and non-allergen containing product.
5. Failure to maintain gloves used in food handling in an intact, clean, and sanitary condition as required by 21 CFR 110.10(b)(5). On November 30, 2009, a gloved employee was observed to leave the packaging line, touch the refrigerator door handle, move a rack of oat bars within the refrigerator and then return to the packaging line where he touched finished ready-to-eat unpackaged oat bars without changing, washing, or sanitizing his gloved hands.
6. Failure to provide hand-washing facilities that are adequate and convenient as required by 21 CFR 110.37(e). Specifically observed was no sanitary towel service or suitable hand drying devices as required by 21 CFR 110.37(e)(3). Although your firm had cloth towels for hand drying in a cabinet next to the baking room hand sink, employees would have had to open the cabinet to access the towels; moreover, there was no laundry receptacle present in the hand sink area for the collection of cloth towels. It was not observed that your employees were accessing the cloth towels in the cabinet.
Food Safety News asked Stafford for comment via the contact page on Bobo’s website. Food writer Heather Mueller offered this review of Bobo’s last year: “By using organic, non-GMO and vegan ingredients, these bars support sustainable agriculture as well as good health.”
Stafford has 15 working days to respond to FDA.