FDA Warning Letter: Using non-validated and not appropriate Test Methods from an Internet Search is not a good Idea

The U.S. Food and Drug Administration (FDA) has issued a new Warning Letter. The document dated 28 June 2023 was published on the FDA webite on 18 July 2023. It refers to an inspection conducted in February 2023 at a drug manufacturing facility in Kansas, USA. The FDA writes that the company in questions manufactures over-the-counter (OTC) topical drug products, e.g. antibacterial hand soaps and hand sanitizers.

The Warning Letter lists the following main violations:

  • QU oversight: The Quality Unit (QU) did not provide adequate oversight for the manufacture of the products. Documents were not appropriately reviewed and several out-of-specification (OOS) results were not investigated. In addition, an adequate ongoing stability program was missing.
  • Identity testing: Adequate identity testing of each component lot used in the manufacture was not performed. In addition, the company used the suppliers’ certificate of analysis (COA) without establishing the reliability of the suppliers’ test analyses. This concerns propylene glycol and ethanol.
  • Laboratory controls: It was not ensured that the test methods were appropriate for their intended use. In this context, the following quote shows how problematic GMP compliance seems to be in the laboratory: "Your analysts provided our investigator with a non-validated test method from an internet search, which did not appear to be specific for your drug products, nor appropriate for any drug product."

The FDA asked the company to provide, beside others, the following information:

  • An assessment and remediation plan to ensure the QU can effectively function.
  • An assessment of the overall system for investigating deviations, discrepancies, complaints, OOS results, and failures.
  • Several documents related to stability studies.
  • A comprehensive review of the material system.
  • A risk assessment for all drug products that contain propylene glycol and ethanol.
  • An assessment of the laboratory practices.

The FDA concludes that "significant findings in this letter indicate that [the] QU is not able to fully exercise its authority and/or responsibilities" Based on the nature of the GMP violations, the FDA strongly recommends engaging a consultant.

For further information, please see the complete Warning Letter to Fuller Industries Inc. on the FDA website.

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