FDA EIR - MUSHROOM HARVEST INC LLC - May 22, 2013

An FDA contract Good Manufacturing Practices (GMP) inspection was conducted at Mushroom Harvest Inc LLC, located in Trimble, OH, on May 22, 2013. The inspection was performed by the Ohio Department of Agriculture, Division of Food Safety, under the authority of Chapter 3715 Ohio Revised Code, focusing on the firm's manufacturing processes for vegetable products, specifically Reishi Mushroom Powder. During this routine inspection, conducted with General Manager Hunter Ferguson, no objectionable conditions or violations of Good Manufacturing Practices were observed. The report explicitly noted the absence of any regulatory actions, recalls, or prior warnings issued to the firm, either since the previous inspection or during this one. Consequently, no warnings, recommendations, or specific required actions were given to Mushroom Harvest Inc LLC by the inspector. The firm was cooperative throughout the inspection, and the post-inspection discussion with management was favorable. The inspection included general discussions on facility security and sanitizer usage, with FDA educational materials provided.