The FDA sent a warning letter to a Wisconsin chemical company, accusing it of manufacturing hand sanitizer with the same equipment used to produce automotive brake parts cleaner. The FDA contends that Brenntag Great Lakes’ actions violated Current Good Manufacturing Practice (CGMP) regulations.
The issue dates back to inspections, when the FDA alleged that Brenntag used the same equipment to make hand sanitizer and industrial chemicals. The agency asserted in its warning letter that the company stated it would stop using non-dedicated blending tank equipment to make its over-the-counter drug products. However, the FDA said the most recent inspection of the company’s facility in Menomonee Falls revealed that such a change never occurred.
The operation poses a risk as failure to remove active ingredients and product residues from surfaces of manufacturing equipment can lead to contamination, according to the FDA.
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The agency is asking Brenntag to respond to the letter by confirming whether it will stop making drugs on shared equipment. The company must also provide a plan showing how it intends to manufacture pharmaceutical and non-pharmaceutical products at its facility separately. Finally, the FDA wants Brenntag to provide a review of its production records to determine if it produced other drug products on non-dedicated equipment.
IEN reached out to Brenntag and the company’s global communications leader of North America, Raquel Sheppard, responded in an email, “Brenntag conducted a thorough review of its production records and found the alleged issue related to a documentation error, which Brenntag has addressed. Brenntag established that the product cited in the letter was not produced on shared equipment and has confirmed this to the FDA. In addition, Brenntag is also working to revise its CGMP controls to establish that all alleged issues have been addressed.”
Brenntag Great Lakes is a part of Brenntag North America, which is a subsidiary of Brenntag SE. The global chemicals and ingredients distributor serves multiple industries, including batteries, beauty and personal care, lubricants and energy.