FDA EIR - Sciegen Pharmaceuticals Inc - March 16, 2018

This FDA Establishment Inspection Report documents a post-approval inspection of Sciegen Pharmaceuticals Inc., a non-sterile generic prescription drug manufacturer located in Hauppauge, NY. The inspection occurred from March 12 to March 16, 2018. Its primary purpose was to assess post-approval compliance for Fluoxetine capsules and Hydrochlorothiazide tablets, and to verify the implementation of corrective actions from a previous FDA inspection conducted between December 29, 2014, and January 9, 2015. The earlier inspection had identified an issue with the quality control unit's adherence to procedures, specifically concerning an inadequate laboratory investigation into duplicate sample testing for Metformin Hydrochloride Tablets. The current inspection, performed under Compliance Program 7346.843 for post-approval audits, concluded without any new inspectional observations or findings (FDA-483) being issued. This indicates that the firm's operations for the inspected products and its response to previous issues were found to be satisfactory. The inspection was classified as "No Action Indicated," signifying compliance with regulatory standards in the areas reviewed.