# FDA 483 - EuTech Scientific Services Inc - December 28, 2021

Source: https://www.keypedia.com/records/483/eutech-scientific-services-inc/ccd9539a-b0a2-4578-90be-d855bff0c256

> FDA 483 for EuTech Scientific Services Inc on December 28, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: EuTech Scientific Services Inc
- Inspection Date: 2021-12-28
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: An FDA inspection of EuTech Scientific Services Inc, a control testing laboratory in Highland Park, NJ, revealed significant deficiencies in laboratory control mechanisms and quality control unit oversight. The firm failed to consistently follow and document established test procedures, maintain control over test sheets and notebooks, and ensure data integrity. Additionally, the quality control unit lacked adequate authority to review electronic data, conduct thorough investigations, and approve equipment calibration records.

## Related Officers

- [Robin P. Mathew](https://www.keypedia.com/people/robin-p-mathew/35f4a085-58b8-4208-a648-ef2d533e1ece)
- [Director, Enterprise Regulatory Compliance](https://www.keypedia.com/people/nicholas-a-violand/c0c3ee7a-8adb-43d2-974c-06220ef8e8eb)

Company: https://www.keypedia.com/companies/eutech-scientific-services-inc/5b5a3795-3490-419b-8bee-813f26d73fd5

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248