FDA Warning Letter: Potentially Carcinogenic Contaminants in Hand Sanitizers

Recently, you could read about an FDA Warning Letter to a South Korean manufacturer of OTC drug products with a facility registered in the U.S. as a manufacturer of over-the-counter (OTC) drug products, including hand sanitizers. During an U.S. Food and Drug Administration (FDA) laboratory testing of a batch of one of these hand sanitizers, the impurity benzene was detected.

Now, the FDA has again found genotoxic and potentially carcinogenic impurities in hand sanitizers. In this case, it is about an American manufacturer in whose products benzene, acetaldehyde and acetal impurities were detected at unacceptable levels.

FDA Warning Letter

In a Warning Letter dated September 1, 2022, the FDA writes that it inspected the company's drug manufacturing facility in California from February 14 to March 11, 2022. This inspection followed FDA laboratory testing of a batch of hand sanitizer manufactured at the facility, which was found to contain unacceptable levels of impurities.

The FDA has not received a response from the company regarding corrective actions to the observations identified during the inspection in the Form FDA 483. The company also failed to respond to previous inquiries from the FDA or responded only after repeated requests.

CGMP Violations

During the FDA inspection, the following CGMP violations, among others, were found:

• The company failed to implement written procedures to establish a Quality Unit (QU) with the CGMP responsibilities and authority to oversee the manufacture of the OTC drug products.
• The QU failed to implement adequate oversight and controls for the contract manufacturers of the firm's OTC drug products.
• The firm lacked adequate batch and control records that document the manufacturing operations. For example, manufacturing batch records for filling operations could not be provided.

Distribution of Damaged Goods?

The Warning Letter further mentions that a significant amount of the hand sanitizer inventory was destroyed in a fire at the facility. The company provided a list of the remaining stock that it said it still intended to distribute. Among them were bottles of hand sanitizer. The FDA has concerns about this and points out that "per 21 CFR 211.208, any drug products that have been subject to improper storage conditions including temperature extremes and smoke shall not be salvaged and returned to the marketplace."

Conclusion

The FDA listed a number of actions and told the company to correct any violations promptly.

More details can be read in the Warning Letter to Virgin Scent Inc. dba Artnaturals published on the FDA website.