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

Source: https://www.keypedia.com/records/483/amish-origins-management-llc/4c17f1c7-8968-4886-9517-9987e203afd6

> FDA 483 for Amish Origins Management, LLC on January 10, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Amish Origins Management, LLC
- Inspection Date: 2025-01-10
- Product Type: drugs
- Office Name: Denver District Office
- Summary: 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.

## Related Officers

- [Medical Officer at FDA](https://www.keypedia.com/people/brittny-c-cargo/a3479241-5390-4ddb-b892-df0bac1c89cf)

Company: https://www.keypedia.com/companies/amish-origins-management-llc/49c30127-92ad-4dc7-aca7-84a5c18d1526

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face