Breaking News! JOINN (Suzhou) Successfully Passes FDA Inspection, Global Compliance Capabilities Validated by a Premier Regulatory Authority
In May 2026, the drug safety evaluation facility of JOINN Laboratories — JOINN (Suzhou) — underwent an on-site inspection conducted by the U.S. Food and Drug Administration (FDA). The facility's quality management system fully meets the requirements of FDA GLP regulations, and the inspection was successfully concluded with outstanding performance.
Passing the Unannounced Inspection Demonstrates Robust Quality Excellence
This marked JOINN's first full unannounced inspection under the FDA's "door-knock inspection" programme, which the regulator rolled out for overseas GLP institutions starting in 2025. Adhering to FDA GLP rules and the world's most stringent regulatory standards for pharmaceutical R&D, FDA inspectors carried out an exhaustive, in-depth review covering core areas: organizational structure and personnel, facility and equipment operation, quality management system, computerized system governance, study operational protocols, raw data integrity, and animal welfare safeguards. Inspectors also performed end-to-end traceability audits on multiple completed and ongoing nonclinical safety evaluation studies.
Successful clearance of this inspection represents another high-level authoritative validation of JOINN's mature, globally aligned quality management system. It further consolidates the Company's leading position in global nonclinical drug evaluation and provides strong impetus for Chinese innovative medicines to accelerate their global market entry.
Six Successful Clearances Establish JOINN as a Benchmark for Compliance Among Chinese CROs
This is JOINN's sixth successful FDA GLP on-site inspection, and the sixth cumulative FDA official endorsement across its two core sites in Beijing and Suzhou. As China's first private CRO to receive and pass an FDA GLP inspection back in 2009, JOINN has always regarded compliance as the lifeline of the enterprise, consistently building and refining its quality management system to the highest standards.
Global Recognition Fuels Faster Globalization of Chinese Innovative Drugs
The successful FDA inspection is a natural outcome of JOINN's long-standing commitment to its core principle of "Quality First". As one of China's earliest CROs specializing in nonclinical drug evaluation, the Company has established an international quality management system spanning the entire drug lifecycle. It holds GLP accreditations from China's NMPA and OECD GLP certification via Poland (an EU Member State), and has repeatedly passed GLP inspections by South Korea's MFDS and Japan's PMDA, alongside AAALAC accreditation for animal welfare. Its evaluation packages satisfy drug registration requirements in major countries and regions worldwide. In September 2025, JOINN's Beijing and Suzhou facilities simultaneously obtained and renewed OECD GLP certification; notably, the Suzhou site has successfully renewed its GLP qualification six consecutive times, solidly demonstrating the sustained stability and maturity of the Company's quality system.
Upholding its mission: "Safety Assessment and Life Cycle Monitoring for Your Pharmaceutical Innovations", the Company will continue to deliver rigorous standards and professional services to advance global innovative drug R&D and safeguard human health.
