FDA EIR - InvaGen Pharmaceuticals, Inc. - December 19, 2018

An FDA Pre-Approval Inspection of InvaGen Pharmaceuticals, Inc., located in Central Islip, NY, was conducted from December 10-19, 2018. The inspection, focusing on cGMP compliance for drug manufacturing and pre-approval for products like Vigabatrin for Oral Solution, revealed three significant observations documented on an FDA Form 483. Key issues included a failure to maintain active pharmaceutical ingredients under quarantine until release, with one instance where material was used in manufacturing before laboratory clearance. Secondly, the company lacked a scientifically rational or statistically sound sampling plan for in-process and finished product testing, specifically for Vigabatrin sachets. Lastly, automatic and mechanical equipment calibration was deficient, as data loggers for a stability chamber were not placed in critically identified temperature/humidity spots according to qualification reports. Verbal observations also highlighted constant issues with capsule check weighing rejections, the absence of secondary leak testing for sealed sachets (only visual inspection), and improper storage of reserve samples (open boxes, incorrect orientation). Operating under FDA's Good Manufacturing Practice regulations (21 CFR Part 211), InvaGen Pharmaceuticals' management acknowledged all observations and committed to implementing corrective actions, including developing a statistical sampling program and addressing equipment calibration and storage deficiencies. The effectiveness of these promised corrections will require further verification.