# FDA 483 - Fortrea, Inc. - April 23, 2025

Source: https://www.keypedia.com/records/483/fortrea-inc/89466d42-c426-40e4-909a-339218cea018

> FDA 483 for Fortrea, Inc. on April 23, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Fortrea, Inc.
- Inspection Date: 2025-04-23
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Between April 14 and April 23, 2025, the U.S. Food and Drug Administration (FDA) conducted an inspection of Fortrea, Inc., a Contract Research Organization (CRO) located in Shanghai, China. The inspection identified significant deficiencies in the firm’s oversight and monitoring of clinical study protocols. The primary violations involved a failure to ensure the study was conducted according to the established investigational plan. Specifically, the FDA noted a systemic breakdown in managing data queries. While the firm’s monitoring plan required resolving queries within five days, over 200 queries remained unaddressed for more than 50 days. Additionally, Fortrea failed to properly monitor investigational product accountability. Significant protocol deviations, such as patient overdoses, were inconsistently classified or downgraded without clinical justification. There were also numerous instances of missing drug kits and incomplete records regarding returned medication. Despite prior interventions, the firm failed to implement effective corrective actions to prevent these recurring issues. These observations were issued under the regulatory framework of Section 704(b) of the Federal Food, Drug, and Cosmetic Act. While these findings do not represent a final agency determination, Fortrea is expected to address these concerns. The firm should submit a formal response outlining its corrective actions or any objections to the findings to the FDA to ensure future compliance with clinical research standards.

## Related Officers

- [Scott N. Lim](https://www.keypedia.com/people/scott-n-lim/d5e7745a-d804-48d1-8f3b-a94a8d4aed8a)

Company: https://www.keypedia.com/companies/fortrea-inc/a8ff525c-a1a0-45d0-bfd9-548ed3e4c30e

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8