WARNING LETTER
CMS #615938
December 1, 2021
Dear Mr. Bergstein:
The United States Food and Drug Administration (FDA) and Virginia Department of Agriculture and Consumer Services (VDACS) jointly inspected your ready-to-eat (RTE) hummus manufacturing facility located at 15900 Sabra Way, South Chesterfield, Virginia, from April 28, 2021 through May 6, 2021. The inspection was initiated by FDA and VDACS 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). After being notified by FDA on March 26, 2021, you initiated a Class I voluntary recall of your Sabra Classic Hummus product.
During a joint inspection of your facility, FDA and VDACS Investigators found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117). At the conclusion of the inspection, the Investigators issued you an FDA Form 483, Inspectional Observations. Based on FDA’s inspectional findings, we have determined that the RTE hummus products manufactured in your facility are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)], in that they were prepared, packed or held under insanitary conditions whereby they may have been contaminated with filth or rendered injurious to health. In addition, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule (located in subparts A, C, D, E, F, and G of part 117) is prohibited by section 301(uu) of the Act [21 U.S.C. § 331(uu)].
Additionally, the presence of Salmonella Havana in your RTE hummus products, as evidenced by the laboratory analysis of FDA’s retail sampling, causes your recalled Classic hummus products to be adulterated within the meaning of section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(1)] in that they bear or contain an added poisonous or deleterious substance which may render them injurious to health. You may find the Act and further information about the CGMP & PC rule through links in FDA’s home page at www.fda.gov.External Link Disclaimer
We received your written responses on May 27, 2021 and July 8, 2021, which describe your completed and planned corrective actions. After reviewing the inspectional findings and responses you provided, we are issuing this letter to advise you of FDA’s concerns and provide detailed information describing the findings at your facility.
FoodWorld 