# FDA 483 - Element Materials Technology Canada Inc. - October 18, 2019

Source: https://www.globalkeysolutions.net/records/483/element-materials-technology-canada-inc/22857589-3e65-4658-adc8-de72d91c3b07

> FDA 483 for Element Materials Technology Canada Inc. on October 18, 2019. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Element Materials Technology Canada Inc.
- Inspection Date: 2019-10-18
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Element Materials Technology Canada, Inc., a control testing laboratory in Mississauga, received two observations during an FDA inspection. The observations highlight deficiencies in documenting second-person review of electronic laboratory records, particularly for HPLC data, and inadequate root cause determination in non-conformance investigations. These issues point to concerns with data integrity and the effectiveness of the quality control unit's procedures.

## Related Documents

- [483 - 2019-09-20](https://www.globalkeysolutions.net/records/483/element-materials-technology-canada-inc/ef379147-6ebc-4714-b6c4-8327f614c4f0)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/edmund-f-mrak/a43cf86a-c020-4948-bff6-358b2453908a)

Company: https://www.globalkeysolutions.net/companies/element-materials-technology-canada-inc/c806fa60-ad44-4fcb-8287-fcb954bcbcf4

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1