FDA 483 - Elvi Pharma LLC - March 25, 2022

Elvi Pharma LLC, an OTC drug manufacturer and packager in Piscataway, NJ, was cited for numerous significant deficiencies during an FDA inspection. The firm failed to adequately clean and maintain equipment, lacked critical validation studies for cleaning and processes, and did not have proper laboratory controls or a stability testing program for its drug products. Additionally, issues with equipment calibration, maintenance, and employee cGMP training were noted, indicating a broad lack of adherence to good manufacturing practices.