# FDA 483 - Eurofins Pharma Bioanalytics Services US Inc. - August 21, 2015

Source: https://www.keypedia.com/records/483/eurofins-pharma-bioanalytics-services-us-inc/474223fd-862a-43f8-b2c0-b18aa58006bc

> FDA 483 for Eurofins Pharma Bioanalytics Services US Inc. on August 21, 2015. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Eurofins Pharma Bioanalytics Services US Inc.
- Inspection Date: 2015-08-21
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: An FDA inspection of Eurofins Pharma Bioanalytics Services US Inc. in St. Charles, MO, revealed significant deficiencies in their bioanalytical laboratory operations. The firm failed to follow established standard operating procedures for sample handling and deviation investigations, maintain adequate documentation, and adhere to study plans. Critical issues included the exclusion of data without defined criteria and the incomplete reporting of method validation data, indicating a lack of robust quality control and data integrity practices.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/kara-a-scheibner/63643a3f-4a8e-4dcc-8f1a-6fcf98519aad)
- [Investigator](https://www.keypedia.com/people/brett-r-havranek/6a4eaba0-a8df-40f6-a21d-45ec5a0e9f6b)
- [Maheen Wahab Abbasi](https://www.keypedia.com/people/maheen-wahab-abbasi/77574a7c-da72-4906-8d7e-6b5f7b3fb487)

Company: https://www.keypedia.com/companies/eurofins-pharma-bioanalytics-services-us-inc/130e92c9-9de7-4c8f-8fe1-35adeff50c67

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8