FDA 483 - Sciegen Pharmaceuticals Inc - September 02, 2022

An FDA inspection of Sciegen Pharmaceuticals Inc. in Hauppauge, NY, identified two significant observations. The firm's written procedures for equipment cleaning and maintenance were found to be inadequate, lacking sufficient detail for methods, materials, and sampling locations. Additionally, several pieces of automatic, mechanical, and electronic equipment, including coating machines used for Clopidogrel and Levetiracetam tablets, were not calibrated across their intended operating ranges.