InvaGen Pharmaceuticals, Inc. – FDA EIR, May 26, 2015

An FDA post-approval inspection of InvaGen Pharmaceuticals, Inc. in Hauppauge, NY, conducted from May 13-26, 2015, identified significant deficiencies in the company's quality control unit. The inspection, performed under the cGMP regulatory framework and specific compliance programs, resulted in an FDA 483 citing four main observations.InvaGen failed to routinely employ its Corrective And Preventive Action (CAPA) system as described in its own procedures. This omission hindered the effective tracking and evaluation of corrective actions for recurring issues, such as numerous analyst errors and laboratory deviations, which were instead managed through less robust change controls. A critical issue highlighted was the company's inability to determine the root cause or full extent of discoloration in its Hydroxyzine HCl Tablets, despite a history of customer complaints and an unsuccessful prior attempt to resolve the problem by changing the tablet coating. Furthermore, an investigation into a complaint involving mixed tablets from a sealed bottle was deemed outside InvaGen's scope without documented communication or investigation by its contract packager, violating the spirit of their quality agreement. Lastly, the quality agreement with a marketing partner lacked explicit definitions for communicating complaint investigations and resolutions to end-users.Implicitly, InvaGen is required to reinforce its quality control procedures, rigorously implement its CAPA system, conduct thorough root cause analyses for product defects, ensure comprehensive investigations involving all relevant partners, and establish clear communication protocols in its quality agreements.