FDA EIR - Sciegen Pharmaceuticals Inc - June 21, 2019

An FDA inspection of ScieGen Pharmaceuticals Inc. in Hauppauge, NY, was conducted from June 10 to June 21, 2019. This routine inspection, focusing on Current Good Manufacturing Practices (cGMP) for generic prescription drug manufacturing under the Food Drug and Cosmetic Act, identified three significant observations. The primary issue cited was the company's failure to thoroughly investigate unexplained discrepancies in distributed batches, specifically inadequate Out-of-Specification (OOS) investigations for product assay and dissolution testing. Furthermore, the inspection revealed a lack of comprehensive written procedures for production and process controls, notably concerning blend hold time studies. A third observation highlighted deficiencies in master production and control records, which lacked complete manufacturing and control instructions, including unwritten verification steps in batch records. These issues indicate shortcomings in quality control and documentation processes crucial for ensuring product identity, strength, quality, and purity. At the conclusion of the inspection, a Form FDA 483 detailing these observations was issued to the Chief Operating Officer, Mr. Siva Reddy Palempalli Venkata, who verbally committed to providing a response to the agency within 15 business days, outlining plans for corrective and preventive actions.