FDA Issues Warning Letter to Marshall's Traditional Healthcare for Inadequate Product Testing

The U.S. FDA has issued a Warning Letter to Marshall's Traditional Healthcare CC (dated February 10, 2025) for failing to adequately test microbiological quality in its drug products. The company did not perform necessary laboratory tests to verify compliance with identity, strength, and purity specifications before batch release, nor did it ensure products were free from objectionable microorganisms.

The FDA rejected the company’s response, citing insufficient details on proposed testing procedures and a lack of retrospective risk assessment for previously released batches. The agency stressed that without adequate testing, there is no scientific assurance that products meet required standards.

FDA Compliance Requirements

Marshall’s must:

• Undergo an independent laboratory assessment covering procedures, methods, equipment, and analyst competency.
• Submit a detailed remediation plan to improve testing effectiveness.
• Provide chemical and microbial specifications along with test methods for batch release decisions.

Further details are available in the FDA’s official Warning Letter.

17-03-2025