FDA 483 - Amish Origins Management, LLC - January 10, 2025

Amish Origins Management, LLC, an OTC drug manufacturer in Worland, WY, was cited for significant deficiencies across its quality system. The inspection revealed a lack of written procedures, inadequate stability testing, insufficient finished product and raw material testing, and deficient batch records. These issues indicate a systemic failure to adhere to current Good Manufacturing Practices.