InvaGen Pharmaceuticals, Inc. – FDA EIR, May 26, 2017

An FDA inspection of InvaGen Pharmaceuticals, Inc., located in Central Islip, NY, was conducted from May 18 to May 26, 2017. This comprehensive inspection covered both current Good Manufacturing Practices (cGMP) and a Pre-Approval Inspection for ANDA 77222-S009, specifically for Fosinopril Sodium Tablets. The inspection, initiated following a change in ownership, identified three significant observations.Firstly, master production and control records were found incomplete. Critical process parameters for drug product packaging were not adequately defined, and an out-of-specification total weight for a product lot was released without proper investigation, indicating a lack of thorough review by the Quality Assurance Unit.Secondly, the quality control unit failed to adequately ensure procedures impacting drug product quality. Cleaning validation protocols were approved without precisely identifying the hardest-to-clean locations for swab sampling, and recovery studies lacked scientific rigor. The justification for the longest campaign length between cleanings was also deemed insufficient for packaging equipment.Lastly, drug products were not stored under appropriate temperature and humidity conditions. The firm's warehouse temperature mapping studies were inadequate, relying on single daily data points rather than continuous monitoring, and failed to include the raw material storage area. These deficiencies were formally presented to InvaGen management via an FDA-483 form. The company is required to submit a written response outlining corrective actions within 15 business days for FDA evaluation, which will impact the pending ANDA approval.