FDA WARNING_LETTER - Sabra Dipping Company, LLC - May 06, 2021
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
The FDA and VDACS jointly inspected Sabra Dipping Company, LLC's ready-to-eat (RTE) hummus manufacturing facility in South Chesterfield, Virginia, from April 28 to May 6, 2021. This inspection was prompted by a retail sample of Sabra Classic Hummus testing positive for *Salmonella Havana*, leading to a Class I voluntary recall on March 26, 2021.
The inspection revealed serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (21 CFR Part 117), rendering RTE hummus products adulterated under 21 U.S.C. § 342(a)(4) and § 342(a)(1).
Key violations include: 1. **Inadequate Hazard Analysis (21 CFR 117.130(a)(1))**: The hazard analyses did not clearly identify hazards requiring preventive controls, particularly for *Salmonella* in tahini, environmental pathogens in RTE products exposed to the environment, and biological hazards in spices/seasonings and frozen vegetables. The firm's "Pre-Requisite Programs" were not clearly distinguished as preventive controls. 2. **Inadequate Environmental Monitoring Verification Procedures (21 CFR 117.165(b))**: The firm lacked written corrective action procedures for pathogens detected in finished products via
ID · d8e3c587-c01e-4902-b6b8-1da1d58cc5f7
Full citation text and observation details available on the Dashboard.