FDA Warning Letter: Too low Ethanol Content in Hand Sanitizer Products

There has been a recent accumulation of Warning Letters from the U.S. Food and Drug Administration (FDA) to manufactures of hand sanitizer products. In the recent past, the FDA has issued, among others, the following Warning Letters addressed to such firms:

• FDA Warning Letter to Drug Manufacturer in Puerto Rico
• FDA Warning Letter again Highlights the Importance of Analytical Testing for Hand Sanitizers Manufacturers
• FDA Warning Letter for Chinese OTC Hand Sanitizer Drug Products Manufacturer
• FDA Warning Letter: Potentially Carcinogenic Contaminants in Hand Sanitizers
• FDA draws consequences for poor quality of hand disinfectants and UV Wands

Now, a further Warning Letter to a company in New Jersey was published, which fits into this series. The document dated 01 September 2022 was posted on the FDA's website on 29 November 2022. In this case, FDA laboratory analyses showed that the ethanol content of several batches was too low. In addition, the FDA has also found numerous GMP violations. There was already a lack of the necessary basic SOPs. 

Too Low Ethanol Content

In the Warning Letter, the FDA writes that one of the products"is labeled to contain 65% volume/volume (v/v) of the active ingredient alcohol (ethanol). However, FDA laboratory testing of batches of this product distributed in the U.S. market found that the drug product contained a range of 48 – 57% v/v ethanol."

In another case, the product was labelled to contain 70% v/v ethanol, but FDA laboratory testing of a batch of this product found that the drug product contained only 55% v/v ethanol.

Further CGMP Violations

During an FDA inspection, the investigators observed specific GMP violations. These could not be resolved by the company's response to the Form FDA 483 which preceded the Warning Letter.

The firm failed to have adequate procedures and personnel with the CGMP responsibilities for oversight for the manufacture of the OTC drug products. "Procedures for investigations, recalls, complaint handling, the approval of manufacturing instructions, and the evaluation and approval or rejection of finished drug product batches before release to the market"  could not be provided.

Furthermore, the FDA mentions

• inadequate process controls,
• inadequate cleaning controls,
• inadequate water system design and controls.

In the end, the firm also failed to perform adequate drug product testing prior to release to the market.

For more information, please see the complete Warning Letter to Shuzy Rock Inc. on the FDA's website.