Regis Technologies successfully completed a recent U.S. FDA audit with no objectionable findings and no Form 483 observations. This is the third inspection in a row for Regis demonstrating compliance.
 
The 12-day inspection focused on Regis’ Quality and Production systems to support its FDA registration and ongoing manufacture of clinical and commercial active pharmaceutical ingredients (APIs).
 
FDA investigators use Form 483 to record observations of non-compliance with the agency’s current Good Manufacturing Practices (cGMP) standards.
 
Senior Quality Assurance Associate, Shellene Rodriguez, said, “We would not be able to have three consecutive FDA inspections with no 483s without the hard work of each and every employee.”
 
At its 36,000 sq.-ft. facility near Chicago, the company provides synthesis, separations, and manufacturing services to pharmaceutical and biotechnology companies. Regis offers regulatory support services, as well as access to its chromatography products and services.