FDA EIR - Vertice Pharma Management Corp - August 29, 2018

Vertice Pharma Management Corp. underwent its first FDA Pre-Approval inspection from August 27-29, 2018, as a contract testing laboratory in Bridgewater, NJ. The inspection, conducted under Compliance Programs 52832 and 56002, focused on the firm's readiness for commercial manufacturing, conformance to application for an ANDA held by VistaPharm, and data integrity. While no FDA Form 483 was issued, three verbal observations were discussed with management, who agreed to initiate corrective actions.

Key issues identified included the absence of a written procedure defining the Quality Unit's roles and responsibilities, insufficient detail captured in change control documentation, and the use of non-validated, uncontrolled spreadsheets for critical GMP calculations (assay and impurity). These spreadsheets were not password-protected and were accessible to all analysts, raising data integrity concerns. Other observations noted were incomplete laboratory logbooks for sample receipt status and pH meter usage, a purified water conductivity out-of-specification result, and a dissolution procedure lacking a specific pre-testing step.

Management committed to addressing these observations, including updating change control processes for better detail, ensuring no GMP testing occurs in the R&D area, revising logbook procedures, enhancing shipping condition controls, updating the water quality SOP, and either validating existing calculation spreadsheets or integrating calculations into chromatographic software.