FDA 483 - Element Materials Technology Ann Arbor, LLC - September 09, 2022

This FDA Form 483 report details significant deficiencies at Element Materials Technology Ann Arbor, LLC, a contract testing laboratory. The inspection revealed critical issues with data integrity, including inadequate controls over computer systems, lack of audit trail review, and non-attributable electronic records. Additionally, the firm's quality control unit failed to routinely review instrument logbooks for stability chambers, indicating a lapse in quality oversight.