FDA 483 - Sannova Analytical LLC. - November 01, 2024

An FDA inspection of Sannova Analytical, LLC, a biopharmaceutics analytical facility in Somerset, NJ, from October 28 to November 1, 2024, identified one observation. The observation concerned the firm's conduct of a protocol where concentrations were not reported as final in the study report, and data was retrospectively excluded. This indicates a concern regarding data integrity and reporting practices.