(An Autonomous Body Recognized by Ministry of Commerce & Industry, Government of India)
FDA Warns Manufacturer Over “Memory-Based” Practices and Unsafe Products
On May 29, 2025, the FDA issued a Warning Letter to Amish Origins Management, LLC after inspecting its Worland, Wyoming facility. Inspectors were alarmed to find that manufacturing procedures were not documented but instead “committed to memory.”
The company also failed to conduct required analytical testing on finished products and raw materials, including identity testing for glycerin—raising contamination risks from toxic substances like diethylene glycol.
Several products, including topical analgesics and a medicated lip balm, were deemed unapproved new drugs and misbranded due to false claims and missing safety warnings. The FDA found these products non-compliant with OTC monographs and thus illegal to market without approval.
Citing serious CGMP violations, the FDA urged the company to hire an external consultant. The full Warning Letter is available on the FDA’s website.
01-07-2025
📰 Recent News
- FDA Warns Manufacturer Over “Memory-Based” Practices and Unsafe Products
- IPEC Releases Updated Risk Assessment Guide for Excipient Manufacturers
- FDA Issues Warning to OTC Drug Manufacturer for Serious Quality Lapses
- ICH Releases Draft Update of M4Q Guideline for Public Comment
- Malta Flags GMP Violations at Two South African Cannabis Facilities
- EMA Updates Clinical Data Publication Guidelines
- FDA Warns AACE Pharmaceuticals Over Lax CMO Oversight
- FDA Flags Serious GMP Violations at Chinese Drug Facility
- Q’Apel Recalls Stroke Device After FDA Warning
- FDA outlines detailed CAPA Procedure in Warning Letter