FDA 483 - Element Materials Technology Ann Arbor, LLC - September 09, 2022
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.
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.
ID · b9a4a39b-0373-4740-ad36-4ea20d15d34e