FDA 483 - Microbiological Testing & Consulting LLC - March 08, 2018

Microbiological Testing & Consulting, LLC, a contract testing laboratory in Chicago, IL, received a Form 483 with five repeat observations. The inspection revealed significant deficiencies in laboratory controls, including inadequate media growth promotion testing and method suitability studies, as well as incomplete laboratory records. Additionally, the firm lacked proper equipment calibration documentation and had systemic issues with its quality control unit procedures, such as missing change control and deviation investigation processes.