FDA EIR - ScieGen Pharmaceuticals, Inc - April 20, 2018

An FDA inspection of ScieGen Pharmaceuticals, Inc., a generic prescription drug manufacturer of solid dosage forms in Hauppauge, NY, was conducted from April 16 to April 20, 2018. This comprehensive inspection, performed under CPGM 7356.002 (Drug Manufacturing Inspections) and CPGM 7352.832 (Pre-Approval Inspections) for ANDAs 210935 and 211232, evaluated all six quality systems including Quality, Laboratory, Facilities & Equipment, Materials, Production, and Packaging & Labeling. No formal regulatory observations (FDA-483) were issued.

However, two verbal observations were discussed with management. These included a lack of sufficient data to support equipment clean hold times and the absence of established procedures for the use and storage of certain materials, requiring proper hold time studies. These issues are crucial for maintaining manufacturing quality and product integrity. Previously, a March 2018 inspection resulted in verbal observations concerning late annual product reviews, inadequate data analysis in continuous process verification, and incomplete vendor qualification for critical raw materials.

The inspection concluded with a "No Action Indicated" (NAI) classification. Despite the verbal observations, the FDA recommended district approval for ANDA 210935 (Fluoxetine Tablets) and ANDA 211232 (Ethacrynic Acid Tablets), suggesting that the identified deficiencies did not warrant formal regulatory action at the time but require corrective measures by the company to ensure ongoing compliance with good manufacturing practices.