# Medpace Bioanalytical Laboratories LLC – FDA 483

Source: https://www.keypedia.com/records/483/medpace-bioanalytical-laboratories-llc/02e793fc-8b2e-4496-8a58-6ecc3e3b0f35

> FDA 483 for Medpace Bioanalytical Laboratories LLC on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Medpace Bioanalytical Laboratories LLC
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: An FDA inspection of Medpace Bioanalytical Laboratories in Cincinnati, OH, revealed deficiencies in method validation practices. The firm failed to include all sample measurements in statistical determinations of accuracy and precision, did not adequately establish stability during method validation, and did not assess potential interferences from multiple metabolites/analytes. These issues indicate a lack of robust analytical method validation.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/kara-a-scheibner/63643a3f-4a8e-4dcc-8f1a-6fcf98519aad)

Company: https://www.keypedia.com/companies/medpace-bioanalytical-laboratories-llc/da88c8d5-c594-435f-a087-af861a1a732f

Office: https://www.keypedia.com/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321