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

The FDA conducted a surveillance inspection of American Blending & Filling Company, Inc. in Waukegan, IL, from January 11 to February 16, 2017. The inspection, targeting an OTC drug and cosmetic manufacturer, identified significant deficiencies in adherence to Current Good Manufacturing Practices (cGMP) for finished pharmaceuticals, as outlined in 21 CFR Part 211. Eight observations were issued on an FDA-483 form. Key violations included inadequate master production and batch records, with evidence of non-validated processing parameters and unidentified equipment being used. The firm exhibited critical data integrity issues, where electronic records for vital documents lacked audit trails and showed discrepancies in creation dates. Furthermore, acceptance criteria for product testing were found deficient, lacking equivalency data to official standards. The company also failed to consistently record and justify deviations from written production and process control procedures, and lacked detailed cleaning validation protocols for shared manufacturing lines. Notably, two observations related to investigating discrepancies and quality control oversight were repeats from a previous 2011 inspection. Management committed to addressing all concerns in a formal written response to the FDA's Compliance Branch within 15 business days, highlighting systemic failures in quality control and record management.