Bakkavor Foods USA, Inc.
Outcome
FDA issued a warning letter on August 8, 2022, after finding 14 of 110 environmental swabs positive for Listeria monocytogenes — including on food-contact surfaces — at Bakkavor Foods USA's Charlotte, North Carolina ready-to-eat facility, and citing the firm's food safety plan for incorrectly concluding environmental Listeria was not a hazard reasonably likely to occur.
Details
Bakkavor Foods USA, Inc. — Listeria on Food-Contact Surfaces / FDA Warning Letter (2022)
Outcome: FDA issued a warning letter on August 8, 2022, after inspecting Bakkavor Foods USA's Charlotte, North Carolina ready-to-eat food manufacturing facility and finding 14 of 110 environmental swabs positive for Listeria monocytogenes — including on food-contact surfaces — while the firm's own food safety plan had incorrectly determined environmental Listeria cross-contamination was not a hazard reasonably likely to occur.
Bakkavor Foods USA, Inc. operates a ready-to-eat food manufacturing facility in Charlotte, North Carolina that produces dips, soups, salad bases, burritos, entrée-style meals, and seafood products. FDA inspected the facility February 7–11, 15, and 23, 2022. The inspection resulted in collection of 110 environmental swabs across the facility; laboratory analysis confirmed that 14 swabs (12.7%) were positive for Listeria monocytogenes, including swabs from food-contact surfaces and areas immediately adjacent to food-contact surfaces.
The central FSMA violation was a deficiency in the firm's hazard analysis. For its "Ready to Eat Cold Salads, Sauces, Sides, and Dressings" product line, Bakkavor's written food safety plan had concluded that pathogens from "Environmental Cross-contamination" constituted a "Hazard Not Reasonably Likely To Occur" — with the stated justification being a lack of historical food-contact surface contamination with Listeria. FDA's inspection directly and empirically refuted that conclusion: Listeria was found on food-contact surfaces during the inspection itself.
The warning letter cited violations of 21 CFR Part 117 for the inaccurate hazard determination and for failing to implement preventive controls adequate to address the Listeria hazard in the facility. No product recall was publicly announced in connection with this warning letter, but the firm was required to submit a written corrective action response within 15 working days.
Primary Source: Bakkavor Foods USA Inc. - 630545 - 08/08/2022 | FDA
How Crucible Prevents This
The firm's food safety plan explicitly stated that environmental Listeria cross-contamination was "not reasonably likely to occur" due to lack of historical contamination on food-contact surfaces — a conclusion that FDA's inspection immediately disproved with 14 positive swabs. Crucible's DECISIONS log would require the firm to document the basis for each hazard determination in the food safety plan and require re-evaluation when environmental monitoring data changes. An accumulation of any positive environmental swab near food-contact surfaces would trigger an open action item requiring documented corrective action — preventing the false confidence that allowed the inadequate hazard determination to persist.
Don't let this happen to your organization. See how Crucible works.
See How Crucible Works