FDA 483 - Element Materials Technology Bend, LLC - November 16, 2018

An FDA inspection of Validation Resources, LLC dba VR Analytical, a contract testing laboratory in Bend, OR, revealed significant data integrity and quality control deficiencies. The firm failed to maintain adequate controls over computer systems, allowing unauthorized access and potential data manipulation, and did not properly investigate or justify deviations from established test procedures, leading to the submission of non-conforming data to customers.