Amish Origins Management, LLC

Warning LetterOpen

Mr. Joshua V. Hansen President Amish Origins Management, LLC 1214 South Flat Road Worland , WY 82401-9539 United StatesFEI 3013538760Issued May 29, 2025Center for Drug Evaluation and Research (CDER)

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3013538760.

Violations6

Issue DateMay 29, 2025

Product TypeDrugs

StatusOpen

Letter Details

Firm: Amish Origins Management, LLC
Location: Mr. Joshua V. Hansen President Amish Origins Management, LLC 1214 South Flat Road Worland , WY 82401-9539 United States
FEI Number: 3013538760
Country: United States
Issue Date: May 29, 2025
Issuing Office: Center for Drug Evaluation and Research (CDER)
Product Type: Drugs
Status: Open

Summary

Amish Origins Management, LLC was cited for significant Current Good Manufacturing Practice (CGMP) violations in the manufacturing of multiple pain relief products (sprays, ointments, creams, and aloe formulations) and a medicated lip balm. The company's manufacturing methods, facilities, and controls failed to meet FDA standards, resulting in their drug products being deemed adulterated and unapproved new drugs introduced into interstate commerce. Additionally, several products were found to be misbranded under federal regulations. These violations were identified during an FDA inspection conducted January 7-10, 2025 at the facility in Worland, Wyoming.

Amish Origins Management, LLC FDA Warning Letter, May 29, 2025