The FDA hit and over-the-counter drug manufacturer in Menomonee Falls, Wisconsin with a Form 483 for repeat violations.
Brenntag Great Lakes, a company northwest of Milwaukee, lacked details in its cleaning instructions for bulk blending tanks, the agency found. The instruction listed “etc.” in place of a rinsing solution and directed employees to “consult the laboratory or quality assurance for assistance” in selecting a rinsate solvent for the blending tanks, which were used to manufacture OTC drug blends and blend bulk industrial materials.
The agency previously flagged the same violation during previous inspections in 2011, 2012 and 2014.
In a repeat observation from 2012 and 2014, the firm lacked a written blending process validation for OTC drug blends including citrus antiseptic handwash, hand sanitizer wipes solution and an acetone and ethanol tincture, to prove they met specifications.