Oregon’s Wild Harvest, Inc. Warning Letter Details

Summary

Oregon's Wild Harvest, Inc. received a warning letter for serious Current Good Manufacturing Practice (CGMP) violations in the production of dietary supplements including Stress Guard, Aller-Aid, Sleep Better, and 12 other products. The FDA's September 2021 inspection identified critical failures including the company's inability to establish proper product specifications for identity, purity, strength, and composition, as well as inadequate contamination limits—violations that rendered the finished dietary supplements adulterated. The company's responses to FDA observations between October 2021 and June 2022 were deemed insufficient to address the underlying CGMP deficiencies.