FDA EIR - Unknown Company - June 21, 2019

ScieGen Pharmaceuticals, Inc., a generic prescription drug manufacturer located in Hauppauge, NY, underwent a routine FDA inspection from June 10 to June 21, 2019. The inspection, conducted under CPGM 7356.002, covered key operational areas including Quality, Production, Facilities and Equipment, Materials, and Laboratory Control Systems. The inspection concluded with the issuance of a 3-item Form FDA 483, highlighting several significant deficiencies.

The main issues identified included a failure to thoroughly review unexplained discrepancies, specifically citing inadequate investigations into out-of-specification results. Additionally, the company lacked written procedures for production and process controls essential for ensuring drug product identity, strength, quality, and purity, evidenced by insufficient blend hold time studies. Finally, master production and control records were found to be incomplete, lacking critical manufacturing and control instructions, such as documented observations in batch manufacturing records.

The inspection was classified as Voluntary Action Indicated (VAI). While not requiring immediate regulatory action, this classification means the company is expected to voluntarily address the observations detailed in the FDA 483 by implementing comprehensive corrective and preventive actions to ensure compliance with regulatory standards.