# FDA EIR - Medpace Reference Laboratories - February 15, 2017

Source: https://www.keypedia.com/records/eir/medpace-reference-laboratories/530b2c4d-3d3f-40c1-8855-e8bcfe5fe70d

> FDA EIR for Medpace Reference Laboratories on February 15, 2017. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: EIR
- Company Name: Medpace Reference Laboratories
- Inspection Date: 2017-02-15
- Product Type: Drugs
- Office Name: Office of Study Integrity and Surveillance
- Summary: An FDA inspection of Medpace Reference Laboratories in Cincinnati, OH, took place from February 9 to February 15, 2017. This high-priority pre-market inspection was initiated by the Center for Drug Evaluation and Research (CDER), Office of Study Integrity and Surveillance (OSIS), and was linked to a specific drug application and a related clinical study site. The inspection adhered to Compliance Program 7348.001.

The scope of the review encompassed the laboratory's operational authority and performance in clinical studies, adherence to protocols, accountability for biological samples, facility conditions, and evaluation of source data. Inspectors examined various records, including laboratory agreements, standard operating procedures, facility maintenance and calibration logs, personnel training documentation, and certifications (CAP and CLIA), as well as electronic system validation for Part 11 compliance.

Significantly, the inspection concluded without any major findings or violations. A Form FDA 483, which details observed deficiencies, was not issued to Medpace Reference Laboratories. As a result, no specific corrective or required actions were mandated by the FDA, indicating that the facility met regulatory expectations during this assessment.

## Related Officers

- [recipient](https://www.keypedia.com/people/traci-a-turner/22416dc5-c1b5-4cd8-b9a4-fc6b20c8611f)
- [company_representative](https://www.keypedia.com/people/nan-plunkett/6a06c31f-7209-4cc4-9428-cc63a238c879)
- [company_representative](https://www.keypedia.com/people/bryan-eppert/70314a44-3a07-44ed-8465-617a052ea3d3)
- [company_representative](https://www.keypedia.com/people/michael-baptist/9e025ff2-dc99-42db-a048-489b3bb0b60e)
- [investigator](https://www.keypedia.com/people/marcia-a-worley/bbcc8e30-05b1-4ad4-85da-17209ace9246)

Company: https://www.keypedia.com/companies/medpace-reference-laboratories/a7ee80f3-4a9b-4595-8184-6036a56becff

Office: https://www.keypedia.com/offices/office-of-study-integrity-and-surveillance/37ba5041-8c75-4b28-be22-3c9638322d38