The U.S. Food and Drug Administration (FDA) has issued a stern warning to Brenntag Great Lakes, LLC, a drug manufacturing facility in Menomonee Falls, Wisconsin, for significant violations of Current Good Manufacturing Practice (CGMP) regulations. The FDA’s inspection, which took place from April 26 to May 5, 2023, revealed critical concerns, particularly around the facility’s use of non-dedicated equipment in manufacturing over-the-counter (OTC) hand sanitizers and automotive brake parts cleaner.
Why It Matters
This violation raises significant concerns about potential cross-contamination risks. The use of the same equipment for producing pharmaceuticals and non-pharmaceutical products like brake cleaner could lead to contamination of drug products. This not only violates CGMP regulations but also poses a threat to consumer safety and product integrity.
- CGMP Violations: The FDA’s inspection uncovered that Brenntag Great Lakes failed to adhere to adequate written procedures for cleaning and maintaining equipment, breaching 21 CFR 211.67(b).
- Use of Non-Dedicated Equipment: Despite previous warnings, the facility continued using the same blending tanks for both OTC hand sanitizer and non-drug products, including brake cleaner.
- Quality Control Unit Failures: The facility’s quality unit (QU) was found lacking in its responsibility to ensure compliance with CGMP and maintaining drug product standards.
- Repeated Offenses: Similar CGMP observations were cited in previous inspections in 2014 and 2019, indicating recurring compliance issues.
- FDA Recommendations: The FDA suggests engaging a qualified consultant to assist in meeting CGMP requirements and conducting a comprehensive six-system audit.
Brenntag Great Lakes must promptly address these serious violations. The FDA requires a detailed plan for corrective actions, including the potential discontinuation of shared equipment usage and an overhaul of the quality control processes. Failure to comply could result in significant regulatory or legal actions, impacting the facility’s operational and commercial functions. The company is given 15 working days to respond to these findings, highlighting the urgency and gravity of the situation.
This case underscores the critical importance of stringent adherence to CGMP regulations in pharmaceutical manufacturing, where the stakes for safety and quality are exceptionally high.