From the desk of the President & CEO

On July 8, 2022, U.S. Food and Drug Administration (FDA) Investigator concluded an inspection of the BTS Research facilities located in San Diego, CA and issued Inspectional Observations on the form FDA-483 that triggered a Warning Letter issued on Oct 20. 2023.

The observations were mainly due to intermittent Study Director review of data, old equipment, and inspections frequency. BTS Research reported the completion of these observations on Nov 8th, 2023, to the FDA. These corrections triggered a more consistent Study Director review of data, the acquisition of new analytical equipment and a streamlined inspection process.

We are very pleased that the corrections were made in a timely manner.  We take the FDA and all inspections seriously.

Respectfully,
Sami Abunadi
President and CEO
BTS Research