FDA issues warning letter to Wauwatosa company making hand sanitizer.

Brenntag Great Lakes, a Wauwatosa chemical company, has received an FDA warning letter alleging it produced hand sanitizer with the same equipment used for brake parts cleaner.

Inspections at the company's Menomonee Falls plant revealed "significant violations," the Oct. 26 letter from the U.S. Food and Drug Administration noted.

The company had agreed to take corrective action but failed to follow through, according to the FDA.

“If you intend to continue manufacturing both pharmaceutical and non-pharmaceutical products at your facility, provide a plan to show how you will maintain appropriate separation with dedicated manufacturing equipment,” the warning letter said.

Hand sanitizer is regulated as an over-the-counter drug. During the COVID-19 pandemic, the FDA published a lengthy list of “do-not-use” hand sanitizers that posed a health risk.

Some of those sanitizers contained methanol or wood alcohol, a toxic substance when absorbed through the skin. Disney-branded sanitizers were the subject of a product recall for the presence of benzene and methanol.

The risk at Brenntag appeared to be cross-contamination of the blending equipment used to make hand sanitizer, solvents, and industrial chemicals including brake parts cleaner, according to the FDA.

“Your firm’s quality systems are inadequate,” the warning letter noted.

“Inadequate removal of active ingredients and product residues from surfaces of non-dedicated manufacturing equipment can lead to contamination of drug products subsequently manufactured on that equipment,” the agency said.

In an email to the Journal Sentinel, Brenntag said the hand sanitizer cited in the FDA letter was not produced on shared equipment and said the alleged issue was related to a "documentation error."

"In addition, Brenntag is also working to revise its CGMP (Current Good Manufacturing Practices) controls to establish that all alleged issues have been addressed," the company said.

The FDA noted that plant inspections at Brenntag in 2014 and 2019 had also revealed manufacturing issues.

“Repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate,” the agency said.

Brenntag Great Lakes is part of Brenntag North America, a subsidiary of Brenntag SE which has more than 600 locations worldwide.

The FDA gave the company 15 working days to respond to the warning letter.

This article originally appeared on Milwaukee Journal Sentinel: Brenntag Great Lakes receives FDA warning letter over hand-sanitizer