17 Apr 2026
From January 26 to 30, 2026, the Labcorp China Bioanalytical Laboratory underwent an unannounced inspection by the U.S. Food and Drug Administration (FDA) and successfully passed with an outstanding result of “Zero observations.”
What are the key characteristics of this inspection?
This was an unannounced “surprise” inspection conducted by the FDA. It is a fast‑paced, high‑intensity inspection with a broad scope and a primary focus on reviewing:
- Quality management systems
- Scientific justification
- Data integrity
- On-site execution
During the five-day inspection, FDA inspectors held in-depth discussions with the laboratory team and commended their professional competence, scientific rigor, responsiveness, and commitment to high data‑quality standards.
Stable: A long-term record of zero observations
This successful inspection marks another milestone for the laboratory. It follows the facility’s first FDA on-site audit in 2015 and three consecutive “Zero observation” outcomes during FDA remote inspections in 2021, 2022, and 2023.
Together, these results demonstrate the laboratory’s consistent commitment to quality and regulatory compliance.
Reliable: Trusted by global partners
Labcorp China Bioanalytical Laboratory has long maintained stable, high-quality operations and aligned its practices with the highest global regulatory standards. For years, the laboratory has upheld:
- A stable and reliable international quality management system
- Deep understanding and rigorous implementation of global regulatory requirements
- Continuous advancement of scientific expertise and professional capabilities
Unshakable: The bedrock of data
Looking ahead, the team will maintain the highest standards, preserving the authenticity, accuracy, and reliability of every dataset.
Through rigorous quality practices and scientific excellence, the team remains committed to providing trusted, high-quality bioanalytical solutions to our customers.