Brenntag Great Lakes, LLC – FDA Warning Letter, May 5, 2023

The FDA inspected Brenntag Great Lakes, LLC, a drug manufacturing facility, from April 26 to May 5, 2023, and found significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, rendering their drugs adulterated. The firm manufactures OTC hand sanitizer and non-drug products using the same equipment.

Key violations include: 1. **Failure to establish and follow adequate written procedures for cleaning and maintenance of equipment (21 CFR 211.67(b))**: The firm continued to use non-dedicated blending tanks for OTC drug products despite a previous commitment to discontinue this practice, posing a cross-contamination risk. 2. **Quality control unit failed to exercise its responsibility (21 CFR 211.22)**: The Quality Unit (QU) did not provide adequate oversight to ensure drug products complied with CGMP and met specifications. This includes failures in ensuring robust procedures, QU oversight, complete batch reviews, and approval of investigations.

These observations are repeat violations from inspections in 2014 and 2019, indicating inadequate executive management oversight. The FDA recommends engaging a qualified CGMP consultant to evaluate operations, perform a comprehensive six-system audit, and assess corrective actions. The firm must respond within 15 working days, detailing corrective actions and a timeline. Failure to address these violations may result in regulatory actions, including seizure, injunction, and withholding of export