FDA EIR - Sciegen Pharmaceuticals Inc - April 02, 2013

An FDA pre-approval and Current Good Manufacturing Practice (cGMP) inspection was conducted at Sciegen Pharmaceuticals Inc, located at 20 Davids Dr, Hauppauge, NY, from March 19 to April 2, 2013. The inspection assessed the firm's Quality, Laboratory Control, Materials, and Facilities & Equipment systems under compliance programs 7346.832 and 7356.002. It also covered drug applications for Hydrochlorothiazide, Fluoxetine, and Irbesartan.

The current inspection served as a follow-up to a previous review in September 2011, which identified two main deficiencies: the firm's practice of universally assigning validity periods for opened volumetric solutions without stability data, and the absence of a written procedure to ensure proper drainage of the water system's delivery hose, which was found with standing water.

Notably, the March-April 2013 inspection found no significant deficiencies. Sciegen Pharmaceuticals Inc had successfully implemented acceptable corrective actions for the issues identified in the 2011 inspection. As a result, the current inspection received a 'No Action Indicated' (NAI) classification, signifying that no further regulatory actions are required based on these findings.