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

Source: https://www.globalkeysolutions.net/records/483/element-materials-technology-bend-llc/f8f04c57-ebb6-41de-a538-92ffc314afea

> FDA 483 for Element Materials Technology Bend, LLC on November 16, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Element Materials Technology Bend, LLC
- Inspection Date: 2018-11-16
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: 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.

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## Related Officers

- [Consumer Safety Officer (Inspector)](https://www.globalkeysolutions.net/people/christopher-r-czajka/42defbf3-ea06-4090-8d51-7da2b07d9e84)

Company: https://www.globalkeysolutions.net/companies/element-materials-technology-bend-llc/4cf94d2e-1223-40e4-9789-20a01ca11d2b

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-vi/6e5a2a08-f464-4979-a759-7b0383370822