FDA 483 - Element Materials Technology Midland Inc. - May 23, 2024

An FDA inspection of Element Materials Technology Midland Inc. in Midland, MI, revealed significant deficiencies across its contract laboratory operations. The firm failed to maintain appropriate controls over computer systems, leading to numerous data integrity issues. Additionally, the inspection found that routine calibration of mechanical equipment was not performed according to a written program, and laboratory records were deficient regarding test method accuracy and reliability.