FDA Warning Letter: "Memory-Based Manufacturing" and Lack of Analytical Testing

The U.S. Food and Drug Administration (FDA) issued a Warning Letter dated 29 May 2025, following an inspection of a pharmaceutical manufacturing facility in Worland, Wyoming, in January 2025.

One of the most notable findings: inspectors were told that “recipes and procedures have been followed for decades. Though not in writing, they have been committed to memory.”

In addition to the lack of documentation, the FDA found that no adequate release testing had been performed for identity, strength, impurities, or microbiological attributes. The company also failed to conduct required identity testing for raw materials, such as glycerin, raising concerns about potential contamination with toxic substances like diethylene glycol (DEG) and ethylene glycol (EG).

Several topical analgesics and a medicated lip balm were classified as unapproved new drugs and misbranded products due to non-conforming label claims and missing safety warnings. The FDA concluded that these products do not comply with applicable OTC monographs and cannot be legally marketed without an approved application.

Due to the breadth and severity of the violations, the FDA strongly advised the company to engage an external CGMP consultant.

The full Warning Letter to Amish Origins Management, LLC is available on the FDA’s website.