# FDA 483 - Element Materials Technology Bend, LLC - June 20, 2025

Source: https://www.keypedia.com/records/483/element-materials-technology-bend-llc/efe21048-13b6-4bfa-a3b2-a90afd70fccf

> FDA 483 for Element Materials Technology Bend, LLC on June 20, 2025. 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: 2025-06-20
- Product Type: drugs
- Office Name: Seattle District Office
- Summary: Element Materials Technology Bend, LLC, a control testing laboratory in Bend, OR, was cited for failing to follow its own written production and process control procedures. The firm introduced new analytical equipment without initiating required change control requests and completing major change control forms. This lapse could potentially compromise the quality and reliability of analytical results and data integrity.

## Related Documents

- [483 - 2018-11-16](https://www.keypedia.com/records/483/element-materials-technology-bend-llc/f8f04c57-ebb6-41de-a538-92ffc314afea)

## Related Officers

- [Tareq W. Haddad](https://www.keypedia.com/people/tareq-w-haddad/5dcb10ba-950c-4dea-b351-0b129675f6d2)
- [Matthew R. Clabeaux](https://www.keypedia.com/people/matthew-r-clabeaux/9acc9b47-4063-4582-ac9a-983a07079495)

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

Office: https://www.keypedia.com/offices/seattle-district-office/9305837f-0738-4075-b444-a55e7a2b8913
