Oregon’s Wild Harvest, Inc.

Warning LetterClosed

Pamela Martin-Buresh, Chief Executive Officer Randal Buresh, President Oregon’s Wild Harvest, Inc. 1601 NE Hemlock Avenue Redmond , OR 97756 United StatesIssued Aug 8, 2022Division of Human and Animal Food Operations West VI

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Violations5

Issue DateAug 8, 2022

Product TypeDietary Supplements

StatusClosed

Closeout LetterApr 19, 2023

Letter Details

Firm: Oregon’s Wild Harvest, Inc.
Location: Pamela Martin-Buresh, Chief Executive Officer Randal Buresh, President Oregon’s Wild Harvest, Inc. 1601 NE Hemlock Avenue Redmond , OR 97756 United States
FEI Number: N/A
Country: United States
Issue Date: August 08, 2022
Issuing Office: Division of Human and Animal Food Operations West VI
Product Type: Dietary Supplements
Status: Closed
Closeout Letter: April 19, 2023

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.

Oregon’s Wild Harvest, Inc. FDA Warning Letter, August 8, 2022