FDA conducted an inspection of Sabra's ready-to-eat (RTE) hummus manufacturing facility located at in South Chesterfield, Virginia. The inspection was initiated after "FDA Investigators collected a sample of Sabra Classic Hummus from retail and subsequent testing revealed the sample contained Salmonella enterica serovar Havana Group G (hereinafter Salmonella Havana). " A recall of the product was initiated after being notified by FDA in March 26, 2021.
The Hazard Analysis was not properly completed - FDA stated, the company did "not clearly indicate whether you determined that a hazard you have identified and evaluated requires a preventive control (except at limited steps where you have identified a CCP). You include an evaluation of identified potential hazards to assess “likelihood/severity” and their specific “risk” (e.g., “low risk,” “high risk”), but your forms do not specifically indicate whether you have determined that a hazard requires a preventive control. Your hazard analysis worksheets, under the column header “Specific control measure to eliminate or acceptably reduce the hazard,” list measures that you call “Pre-Requisite Programs.”....some of the prerequisite programs listed are verification activities rather than preventive control measures for specific hazards (e.g., COA verification, test ingredient). "
The HA "did not clearly indicate whether you determined that pathogens such as Salmonella in your tahini ingredient are a hazard requiring a preventive control. Your facility manufactures various RTE hummus products using ingredients such as tahini that are considered RTE and do not undergo further processing in your facility to significantly minimize pathogens prior to inclusion into your finished product." "Tahini has a known history of contamination with Salmonella, and you should have identified it as a hazard that requires a preventive control, i.e., a supply-chain control, as required by 21 CFR 117.405(a)(1) for a hazard that is controlled by a supplier. It is not clear whether your evaluation of the hazards at the tahini receiving step determined the need for required preventive controls."
The company "did not identify and evaluate whether environmental pathogens are a hazard requiring a preventive control, in accordance with 21 CFR 117.130(c)(ii). You manufacture RTE food products (multiple varieties of hummus) that are exposed to the environment at filling where the food could be contaminated with environmental pathogens, such as L. monocytogenes or Salmonella, and the food does not receive a treatment or otherwise include a control measure (such as a formulation lethal to the pathogen) that would significantly minimize the pathogen."
Other issues included issues with verification and verification actions associated with the environmental monitoring program and some GMP items.
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sabra-dipping-company-llc-615938-12012021
Sabra Dipping Company, LLC
MARCS-CMS 615938 — DECEMBER 01, 2021