FDA Warning Letter: Company Voluntarily Ceases Drug Production

In a recently published Warning Letter dated 25 June 2025, the U.S. Food and Drug Administration (FDA) outlined a series of significant violations of Current Good Manufacturing Practice (CGMP) observed during an inspection of a facility in Utah. The inspection took place in January 2025.

The facility repackages and manufactures OTC drug products. The FDA report cites multiple systemic failures in the areas of stability testing, storage practices, supplier qualification, material testing, finished product release, water system control and documentation.

Key Findings

The findings include:

• No stability program or studies conducted: The firm used expired bulk ethanol hand sanitizer gel for repackaging into smaller units and assigned a two-year expiry date without conducting stability studies. Finished product expiry periods were applied arbitrarily, and there was no evidence to demonstrate product integrity over time.
• Improper storage of ethanol-based products: The FDA writes that bulk totes of ethanol hand sanitizer gel had been stored outdoors since 2020, exposed to fluctuating temperatures far beyond the labelled specifications. Such conditions pose a serious risk of product degradation and non-compliance with labelled storage conditions.
• No testing of incoming materials: Incoming raw materials, including isopropyl alcohol, were not tested for identity, purity, or quality. Instead, the firm relied solely on certificates of analysis (CoAs) from suppliers, without validating these CoAs through periodic testing or qualification protocols. 
• No finished product testing prior to release: Finished batches were released without conducting adequate chemical or microbial testing. In some cases, assay values were merely calculated – not measured – and organoleptic checks (e.g. appearance, odour) were used as the only release criteria.
• Unvalidated water system and microbial risks: The firm was unable to provide adequate documentation demonstrating that the water system is validated and routinely monitored. Water used in manufacturing exceeded appropriate microbiological limits, and alert/action levels were not properly established.

Drug Production Ceased

The FDA emphasized that the absence of testing, validated systems, and written procedures reflects a fundamental lack of control over manufacturing processes. These findings not only raise serious data integrity and product quality concerns, but also increase the risk of contaminated or ineffective drug products entering the market.

During the inspection, the firm provided a document indicating that it would discontinue the manufacturing of various drug products and did not anticipate renewing its registration as an OTC drug manufacturer.

The FDA strongly recommended engaging a qualified GMP consultant in accordance with 21 CFR 211.34 to assist with remediation efforts, should the firm consider re-entering the U.S. drug market.

The full Warning Letter to Nature’s Fusions LLC is available on the FDA's website.