FDA recently published a Warning Letter to dietary supplement manufacturer, Oregon’s Wild Harvest, reporting a laundry list of violations and issues. While the letter details the many quality control issues that the agency observed during its September 2021 facility inspection, and in spite of the Company’s several attempts to address FDA’s concerns, the agency highlights specific concern over failed quality procedures for ensuring that incoming raw materials were free of contaminants. For instance, the FDA reports that on several occasions, the Company approved use of incoming ingredients, despite the Company finding the ingredients contained foreign materials and filth such as pieces of hard plastic, rock material, a AA battery, glass and rodent feces, and potential allergens including wheat grains, tree nut shells, peanut shells, and walnuts. FDA reports that the Company had a practice of removing visible violative components and erroneously believing that the rest of the batch was OK to be used.
FDA also stated compliance issues with the Company’s expiration dating. The Company reportedly advised FDA during the inspection that it had organoleptically (the “smell test”) examined products at expiration and used this exam to support the listed expiration date, but had no other supporting data to demonstrate the product’s shelf life.
FDA’s issuance of the Warning Letter is a strong and critically important reminder for industry to adequately address FDA’s inspectional observations. This includes responding swiftly, completely, clearly, ensuring follow-through on commitments, and providing subsequent updates as promised, to avoid a Warning Letter, and other enforcement action.
