FDA 483 - Microbiological Testing & Consulting LLC - September 16, 2025

Microbiological Testing & Consulting, LLC, a contract testing laboratory in Alsip, IL, was cited for multiple significant deficiencies during an FDA inspection. The firm failed to maintain complete laboratory records, conduct adequate microbiological testing and method suitability studies, and properly qualify and calibrate equipment. Additionally, the quality control unit's procedures were not fully established or followed, and GMP training for personnel was insufficient, with many of these issues being repeat observations from previous inspections.