FDA EIR - American Blending & Filling Company, Inc. - March 16, 2017

An FDA surveillance inspection of American Blending & Filling Company, Inc. in Waukegan, IL, was conducted from January 11 to February 16, 2017, focusing on cosmetic and Over-the-Counter (OTC) drug manufacturing. The inspection identified significant deficiencies, resulting in an eight-point FDA-483 form issued to management, with references to 21 CFR 211 regulations. Key violations included severe data integrity issues within electronic recordkeeping, lacking audit trails and security from alteration. The company also failed to maintain complete and accurate master production and control records, utilizing non-validated processing parameters and unidentified equipment. Batch records were deficient in identifying components, and deviations from established procedures were not consistently recorded or justified. Furthermore, the Quality Control Unit lacked adequate acceptance criteria for product testing and failed to justify observed discrepancies during validation campaigns, leading to the release of products with unreported variations. Sanitation procedures were also found inadequate, with cleaning validation protocols misaligned with actual production lines and cleaning logs often absent. Notably, two observations—failure to investigate discrepancies and inadequate Quality-Control-Unit oversight—were repeat violations from a prior 2011 inspection. Management committed to addressing all concerns in a formal written response to the FDA within 15 business days.