FDA 483 - Brenntag Great Lakes, LLC - August 02, 2019

An FDA inspection of Brenntag Great Lakes, LLC in Menomonee Falls, WI, revealed significant deficiencies in the manufacture of OTC drug blends. The firm was cited for unvalidated cleaning procedures for blending tanks, a lack of written production and process controls including blending process validation and documentation of critical parameters, and the absence of a stability program for OTC products. Many of these issues were repeat observations from previous inspections, indicating persistent non-compliance.