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# CGMP Violations at Oregon’s Wild Harvest
- URL: https://www.fdaweb.com/cgmp-violations-at-oregons-wild-harvest/
- Published: 2022-08-25T12:00:00.000Z
- Updated: 2026-09-14T17:57:23.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152589

A 9/20-9/24/21 FDA inspection at Oregon’s Wild Harvest, Redmond, OR, found serious violations of FDA regulations for current good manufacturing practice (CGMP) in manufacturing, packaging, labeling, or holding operations for dietary supplements. An 8/8 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/oregons-wild-harvest-inc-621842-08082022?ref=fdaweb.com) says specific violations were:

- failing to establish product specifications for the identity, purity, strength, and composition of the finished batch of the dietary supplement, and for limits on those types of contaminants that may adulterate, or that may lead to adulteration of, the finished batch of the dietary supplement to ensure the quality of the supplement;
- failing to ensure that the tests and examinations used to determine whether the specifications are met are appropriate, scientifically valid methods;
- failure of the company’s quality control personnel to reject a component or dietary supplement when an unanticipated occurrence took place during the production and in-process control systems that results in or could lead to the adulteration of a component or dietary supplement; and
- failing to verify that the laboratory examination and testing methodologies are appropriate for their intended use.

The letter says the firm’s responses to the inspection observations were inadequate.

Oregon’s Wild Harvest was told to respond with a list of specific actions it has taken to address any violations, with related documentation and a schedule for completing the corrections.