# FDA 483 - Eurofins BioPharma Product Testing Toronto, Inc. - November 15, 2019

Source: https://www.globalkeysolutions.net/records/483/eurofins-biopharma-product-testing-toronto-inc/9ea62ecd-73de-4e54-b23b-bf428acb10fb

> FDA 483 for Eurofins BioPharma Product Testing Toronto, Inc. on November 15, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Eurofins BioPharma Product Testing Toronto, Inc.
- Inspection Date: 2019-11-15
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Eurofins Experchem Laboratories Inc., a contract testing laboratory in North York, Ontario, was cited for significant deficiencies during an FDA inspection. The firm demonstrated a pattern of inadequate Out of Specification (OOS) investigations, frequently invalidating results without scientific justification or thorough root cause analysis. Additionally, the inspection revealed a severe lack of Quality Unit oversight over controlled documents and incomplete laboratory records, indicating serious data integrity concerns.

## Related Officers

- [Arsen Karapetyan](https://www.globalkeysolutions.net/people/arsen-karapetyan/4000d909-277b-4533-992f-4e3627c8ce40)

Company: https://www.globalkeysolutions.net/companies/eurofins-biopharma-product-testing-toronto-inc/2504ba47-f68d-484f-a267-60ba4e502478

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