FDA EIR - Herb Pharm LLC - March 01, 2018

A routine FDA contract inspection, assigned by the Washington State Department of Agriculture (WSDA), was conducted at Mushroom Harvest, Inc. on March 1, 2018. The company, a medium-sized food manufacturer specializing in dehydrated mushroom powders, was assessed for compliance with regulatory standards. The inspection specifically focused on processing steps for dehydrated turkey tail mushroom powder, storage areas, packaging operations, and product labels. Three key violations of 21 CFR 110 Good Manufacturing Practices (GMPs) were identified. A recurring issue was the lack of essential hand hygiene supplies —soap and paper towels —at a hand wash sink in the harvesting and cleaning room. Additionally, new deficiencies included employees in the packaging room not wearing required beard restraints, a critical personnel hygiene practice to prevent product contamination. Significant pest control lapses were also noted, with numerous spiders, eggs, and live insects observed in the dry rice storage room, harvesting room, and connecting hallway. The firm's owner, George W. Vaughan, was informed of the findings and committed to implementing immediate corrections. Interstate commerce was confirmed for the firm's products, and relevant FSMA fact sheets on Preventative Control, Sanitary Transport, and Intentional Adulteration rules were provided and discussed. A follow-up routine inspection by the State is planned to ensure these violations have been adequately addressed.