A chemical manufacturing facility in Wisconsin has drawn the ire of the Food and Drug Administration for making hand sanitizer with the same equipment it uses to make products with toxic industrial solvents and chemicals, such as automotive brake parts cleaner. The practice is a clear violation of manufacturing standards and could lead to harmful cross-contamination, the FDA said.
The agency sent a warning letter dated October 26 to the maker of the hand sanitizer, Brenntag Great Lakes, LLC, in Wisconsin. The letter, which redacted the name of the hand sanitizer, stated that the agency had found “significant violations” in an inspection in the spring and that the company’s responses since then were “inadequate.”
Toxic hand sanitizers became an alarming problem in the early days of the COVID-19 pandemic, when demand for the germ-fighting gels skyrocketed and manufacturers rushed products to market. Hundreds of products that flooded the market were found to contain methanol, a toxic alcohol that can cause harm via inhalation, ingestion, and skin absorption. Use of the products leads to poisoning, blindness, and even death, the FDA reported.
Though methanol contamination is not the concern in this case, the FDA indicated Brenntag’s hand sanitizer could be contaminated with class 2 solvents, which include those that have irreversible toxicity, including neurotoxicity.
The regulator noted that this isn’t the first time FDA inspectors have warned Brenntag about using the same equipment to manufacture both toxic industrial products and the over-the-counter (OTC) hand sanitizer, which the FDA regulates as a drug product.
“This was noted during a previous inspection,” the FDA wrote in the letter, “and as a corrective action you stated you would discontinue the use of non-dedicated blending tank equipment in the manufacture of OTC drug products. However, our investigator observed that you continued to use non-dedicated blending tank equipment to manufacture OTC drug products.”
According to the FDA, the company allegedly told the regulator that, although it had planned to set up dedicated equipment for the hand sanitizer, this plan was “not effectively communicated to the production team.”
But, in a statement to the Milwaukee Journal Sentinel, Brenntag entirely denied that the hand sanitizer was made on the same equipment and said the alleged violation was due to a “documentation error.” It added that it is revising its manufacturing processes to “establish that all alleged issues have been addressed.”
The FDA went on to note other violations, including failures in quality control and compliance. It required Brenntag to submit a slew of documentation regarding remediation and assessments, and recommended the company hire a consultant to help. The FDA also noted that Brenntag had troubled inspections in 2014 and 2019 for similar problems.
The company has 15 business days to respond.