FDA EIR - Sannova Analytical LLC. - October 07, 2020

Sannova Analytical Inc. underwent a pre-approval inspection by the FDA from September 30 to October 7, 2020. This inspection, conducted under the regulatory framework for abbreviated new drug application (ANDA) approvals, focused on the company's role as a contract testing laboratory for analytical services including Particle Size Distribution, Lead Content, and Elemental Impurities testing. The inspection identified a significant deficiency, documented in an inspectional observation (FDA-483), regarding the company's Quality Control Unit. Specifically, the responsibilities and procedures for this unit were found to be inadequately documented and followed. Key issues included the failure to review audit trails for critical data acquisition systems, such as those used for ICP-MS and particle size analysis, and the absence of established procedures for these reviews. Furthermore, the firm did not investigate multiple electronic data backup failures nor did they perform complete backups as stipulated by their standard operating procedures. Crucially, deviations for these backup failures were not initiated. Additionally, appropriate access for the Analytical Lab Lead and AQA Reviewer to these data acquisition system audit trails was not established. In response, Sannova Analytical Inc.'s management committed to implementing necessary corrections for all observed deficiencies and pledged to provide a written response to the agency within 15 business days.