Oregon’s Wild Harvest, Inc.
FDA issued a warning letter to Oregon's Wild Harvest, Inc. following a September 2021 inspection of their Redmond, Oregon dietary supplement manufacturing facility. The agency found serious CGMP violations including failure to establish adequate product specifications, use of scientifically invalid testing methods (e.g., relying on input calculations rather than validated analytical methods for strength), failure to reject components contaminated with allergens, rodent feces, glass, and other foreign materials, and failure to verify microbial testing methodology. FDA warned that failure to adequately address these violations may result in legal action including seizure and injunction.
Flagged claims (1)
you informed our investigators that your firm had organoleptically examined the products at expiration and used this examination to justify the listed expiration date. You stated that you do not have data supporting the expiration dates listed on the product labels.
Required actions (2)
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.
Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
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