Company Accused of Using Same Equipment to Make Hand Sanitizer, Brake Parts Cleaner

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.