Avance Biosciences announced that its Houston facility was successfully inspected by the U.S. FDA on October 1 through October 4, 2018.  This inspection focused on the firm’s quality management system, operation procedures, and data integrity, as well as various analyses performed on a specific drug product from one of its clients.

As a provider of biological testing services, Avance Biosciences offers a broad range of molecular biology and microbiology assays in compliance with current Good Manufacturing Practices (21 CFR Parts 210 & 211) and Good Laboratory Practices (21 CFR Part 58) to support its clients’ regulatory submissions.

Avance’s chief executive officer, Dr. Xuening Huang said, “We are very pleased with the outcome of our FDA inspection and proud of the outstanding quality of the services that our lab provides.  Our staff is committed to strict adherence to cGMP and GLP regulations and that was reflected in the outcome of this successful inspection.”

Avance’s vice president of Operations, Dr. David Wall said, “Quality is an integral part of our organization. Our laboratory has successfully passed numerous client audits throughout the past several years, and now our first FDA inspection has been completed successfully.  We find that transparency and open communication among all parties are crucial for our success, and have served us well in this case.”

This inspection’s success is a testament to the strength of Avance’s quality management system and its overall commitment to quality. Drug development firms are under the constant scrutiny of the FDA, and must be selective when choosing a testing services provider for their regulatory submissions.