FDA WARNING_LETTER - Pure Ground Ingredients, Inc. - July 14, 2022

The FDA issued a Warning Letter to a dried herbs and spices processing facility in Minden, NV, following an inspection from June 24 to July 14, 2022. The inspection was prompted by a Class 1 Recall for Salmonella in oregano products. The FDA found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (21 CFR Part 117), rendering the firm's ready-to-eat organic dried herb and spice products adulterated under section 402(a)(4) of the Act.

Key violations include the firm's failure to validate process preventive controls, specifically the (b)(4) treatment for Salmonella, a repeat observation from a 2019 inspection (21 CFR 117.160(a)). The firm also failed to implement written corrective action procedures when critical limits were not met, leading to the distribution of products, including Salmonella-positive oregano lots, without reprocessing (21 CFR 117.150(a)(1)), another repeat observation. Additionally, equipment and utensils were not adequately cleanable or maintained (21 CFR 117.40(a)(1)), and the firm failed to report two shipments containing Salmonella-positive raw materials to the Reportable Food Registry as required by Section 417 of the Act.

Despite multiple written responses from the firm detailing corrective actions, the FDA expressed continuing concerns. The firm is required to respond within 15 working days with specific steps taken to address violations and prevent recurrence, including supporting documentation. Failure to adequately address these issues may result in legal action, including seizure and injunction.