# FDA 483 - Element Materials Technology Oakland-Concord - December 21, 2018

Source: https://www.keypedia.com/records/483/element-materials-technology-oakland-concord/ec1cb8e7-5ff4-446a-9ff2-eb0b90dc2b11

> FDA 483 for Element Materials Technology Oakland-Concord on December 21, 2018. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Element Materials Technology Oakland-Concord
- Inspection Date: 2018-12-21
- Product Type: other
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: Microbiology & Quality Associates LLC, a contract laboratory in Concord, CA, received a Form 483 with three observations. The inspection revealed failures in following quality control procedures for sample transport and temperature monitoring, inadequate employee training for critical equipment certification, and a lack of calibration for Biological Safety Cabinet pressure gauges. These issues indicate significant deficiencies in quality system adherence and personnel qualification.

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## Related Officers

- [Kristin M. Abaonza](https://www.keypedia.com/people/kristin-m-abaonza/cf909da8-837d-4dfe-9ccc-288b24d7bba3)

Company: https://www.keypedia.com/companies/element-materials-technology-oakland-concord/30d36985-08bf-4bba-865d-c40e43e3f574

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b