FDA EIR - MUSHROOM HARVEST INC LLC - September 22, 2021

An FDA Good Manufacturing Practices (GMPs) inspection was conducted at Mushroom Harvest Inc LLC on September 22, 2010. Operating under the regulatory framework of Chapter 3715 Ohio Revised Code as an ODA/FDA contract inspection, the routine audit focused on the company's compliance with GMPs, particularly concerning the manufacture of vegetable and milled grain products like Cordyceps. During the inspection, two main issues were identified. Firstly, outside the facility, an accumulation of unused materials and excessive high weeds was observed, creating a potential harborage for rodents. Secondly, within the dehydration area, certain fixtures were not adequately protected from breakage, which could pose a risk of product contamination. The company's President, George Vaughn, was cooperative and agreed to correct these deficiencies by October 6, 2010. Additionally, the inspector recommended that Mushroom Harvest Inc LLC maintain sanitation and pathogen testing records on-site for streamlined review and implement a formal pest control monitoring program. This was the initial inspection of the company's newly relocated facility, and no prior regulatory actions or warnings had been issued.