Sciegen Pharmaceuticals Inc – FDA EIR, Sep 18, 2013

An FDA pre-approval and cGMP inspection of Sciegen Pharmaceuticals Inc., located in Hauppauge, NY, was conducted from September 10 to September 18, 2013. This inspection, covering the company's Quality, Laboratory Control, Material, and Packaging & Labeling systems, followed compliance programs 7346.832 and 7356.002. The inspection was classified as "No Action Indicated" (NAI), meaning no significant deficiencies were found, and no FDA Form 483 was issued. This positive outcome builds upon a prior NAI classification for earlier pre-approval inspections. During the exit meeting, several discussion points were raised to enhance the company's operational controls. These included the need for a more comprehensive definition and procedure for out-of-trend (OOT) results, and developing written procedures for general chromatographic practices, ensuring critical instructions are formally documented and communicated. Additionally, periodic challenges for the newly qualified visual system on the packaging line were suggested, and the importance of documenting method development information in a written report was emphasized. These recommendations aim to further strengthen compliance and quality systems.