FDA WARNING_LETTER - Oregon’s Wild Harvest, Inc. - September 24, 2021

The FDA conducted an inspection of the facility at 1601 NE Hemlock Avenue, Redmond, Oregon, from September 20-24, 2021, revealing serious violations of Current Good Manufacturing Practice (CGMP) for dietary supplements under 21 CFR Part 111. These violations render the firm's dietary supplement products, including Stress Guard and Aller-Aid, adulterated under section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act. Key deficiencies include the failure to establish adequate product specifications for identity, purity, strength, and composition of finished batches (21 CFR 111.70(e)), and the failure to ensure that testing methods used to verify specifications are appropriate and scientifically valid (21 CFR 111.75(h)(1)). Furthermore, quality control personnel failed to reject components or dietary supplements when unanticipated occurrences, such as allergen or foreign material detection, could lead to adulteration (21 CFR 111.113(b)(1)). The firm also failed to verify that laboratory examination and testing methodologies, particularly for microbial contamination, are appropriate for their intended use (21 CFR 111.320(a)). The FDA found the firm's responses to the Form FDA 483 inadequate, citing issues like reliance on input for strength determination and unverified microbial testing methods. The firm is required to notify the FDA within 15 working days of specific corrective actions, including supporting documentation, to prevent recurrence of these violations. Failure to adequately address these issues may result in legal action, including seizure and injunction.