FDA 483 - Brenntag Great Lakes, LLC - May 05, 2023

Brenntag Great Lakes, LLC, a manufacturer in Menomonee Falls, WI, was cited for significant quality control deficiencies during an FDA inspection. The firm failed to ensure proper review and approval of batch records and changes, did not conduct annual product reviews for several products, and exhibited issues with process validation for hand sanitizer manufacturing. Additionally, the inspection revealed unvalidated cleaning procedures for shared equipment and inadequate controls over computerized systems, including the use of a common login for a Gas Chromatography system.