FDA EIR - Primera Analytical Solutions Corp. - December 08, 2017

This FDA Establishment Inspection Report details a pre-approval inspection of Primera Analytical Solutions Corp. in Princeton, NJ, conducted from December 4-8, 2017. The inspection, performed by the FDA's Office of Study Integrity and Surveillance (OSIS) for an in-vivo study submission, focused on the company's bioanalytical unit, including method validation and sample analysis.

At the conclusion of the inspection, a four-item Form FDA 483 was issued. Key observations included insufficient documentation to justify changes in sample concentrations for specific subjects, a lack of long-term stability experiments for residual drug amounts on patches, skin swabs, and envelope/liner samples, and the absence of stability data for processed patches and swabs. Additionally, documentation was inadequate to confirm the actual hours evaluated for solution stability.

Beyond the formal observations, discussions with management highlighted data security concerns regarding an analyst's ability to delete project files from the LCMS system. The FDA also recommended procedures to ensure paper document copies are true representations of originals and requested additional method validation data from a previous inspection. Primera Analytical Solutions Corp. acknowledged these findings and committed to providing a response to the Form FDA 483 within 15 business days.