FDA 483 - Element Materials Technology Midland Inc. - May 23, 2024
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · 5d5f5474-f9ef-402d-b0e2-6fb773de01b3