FDA Warning Letter: Benzene Contamination in Hand Sanitizer

Recommendation

Monday, 29 April 2024 10.00 - 16.00 h

Introduction to the AQCG’s new ECA Guide for an Integrated Lifecycle Approach to Analytical Instrument Qualification and System Validation
Includes USP Speaker Update on the Analytical Procedure Lifecycle

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter dated June 22, 2022, to a South Korean manufacturer of OTC drug products. The facility concerned is registered in the U.S. as a manufacturer of over-the-counter (OTC) drug products, including hand sanitizers.

During an FDA laboratory testing of a batch of one of these hand sanitizers, the impurity benzene was detected. According to the FDA, Benzene impurity levels were found to be between 5 to 6 ppm. After a review of records and other information provided by the manufacturer, the FDA came to the conclusion that the quality assurance within the facility is not functioning in accordance with CGMP requirements.

Release Testing

Based on the review of documents submitted in response to the FDA request for records and other information, the FDA believes that the company did not conduct adequate finished drug product testing on all drug products shipped to the U.S. The hand sanitizer drug product is tested for appearance, odor, pH, viscosity, and specific gravity, but no full release testing is performed.

The FDA points out that "full release testing, including strength and identity testing of the active ingredient, must be performed before drug product release and distribution."

Testing of Incoming Raw Materials

Based on the documents submitted, it appears that the company did not perform its own analytical tests of incoming raw materials, in particular, no identity testing.

According to the FDA, the firm "accepted test results from suppliers without verifying information provided by suppliers." The company has not "established the reliability of [the] component supplier’s analyses through adequate initial validation and subsequent verification of the supplier’s test results at appropriate intervals."

Stability Program

The company could not provide the expiry dates of hand sanitizer drug products. Based on the record review, an adequate stability program to determine appropriate storage conditions and expiration dates was not established.

In this context, the FDA points out the following: "Without appropriate stability studies, there is no scientific evidence to support whether [the] drug products meet established specifications and retain their quality attributes through their labeled expiry."

Conclusion

The FDA placed all drugs and drug products manufactured by the company on Import Alerts. The FDA also notified the public of the unacceptable benzene results in the hand sanitizer drug products.

If the firm intends to resume manufacturing drugs for the U.S. market, the FDA strongly recommends engaging a consultant to assist the firm in meeting CGMP requirements.

The details and further deficiencies can be read in the Warning Letter to Mirfeel Korea Co., Ltd. published on the FDA website.