Another FDA Warning Letter to US Manufacturer of Hand Sanitizers

On 28 February 2023, the U.S. Food and Drug Administration (FDA) has published a Warning Letter, which was already sent on 20 December 2022. The letter is addressed to a U.S. company in Diamond Bar, California, which produces a consumer hand sanitizer.

The agency inspected the firm's drug manufacturing facility in July 2022. During this visit, significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals came to light.

Methanol in Finished Drug Product

According to the FDA, the quality unit (QU) approved a specific active ingredient (API) for use in production without verifying its suitability for use in drug products. Based on the information given in the safety data sheet, this component contains methanol, which, of course, is not an acceptable ingredient for hand sanitizers.

No testing for methanol was performed as part of the release analysis. However, the FDA has calculated that the methanol content is likely to be in an unacceptable range.

Release Testing

In addition to the lack of testing for methanol, the company in general failed to conduct proper release testing. Only pH, viscosity, and clarity testing were performed. Microbial testing and a strength and identity testing of the API were not conducted

Testing of Incoming Components

Furthermore, the FDA writes that the "firm failed to conduct any testing on the components used to manufacture [the] hand sanitizer drug product. [...] Additionally, [the] firm accepts components from [the] suppliers without establishing the reliability of [the] suppliers’ test analyses, and without obtaining [the] suppliers’ certificate of analysis (COA)."

Series of Warning Letters to Manufacturers of Hand Sanitizers

This case is one of a series of Warning Letters sent by the FDA to various hand sanitizer manufacturers in the recent months. The series includes the following examples:

• The Series of Warning Letters to Manufacturers of Hand Sanitizers does not stop
• FDA Warning Letter: Acetaldehyde and Acetal Impurities in Hand Sanitizers
• FDA Warning Letter: Too low Ethanol Content in Hand Sanitizer Products

As a result, this Warning Letter once again shows that manufacturers of hand disinfectants must comply with GMP requirements. The fact that the demand increased significantly during the Corona pandemic does not justify negligence. Especially when, as in the present case, there is a contamination with methanol.

For more information, see the full Warning Letter, which is available on the FDA website.