Regis Technologies, Inc. has successfully passed an FDA audit with no Form 483 observations. Regis’ GMP manufacturing facility, QC lab, and quality systems were part of a detailed inspection that found the company to be in compliance with the agency’s cGMP standards.
Regis provides synthesis, separations and manufacturing services to pharma and biopharma companies for intermediates and APIs from process development and scale-up, through validation and commercial manufacturing, from its cGMP facilities outside Chicago. Regis also offers regulatory support services, as well as access to its chromatography products and services.
“The Regis team of 65 chemists and professionals has had the goal of providing the highest quality services to our customers for almost 60 years,” noted Louis Glunz, chief executive officer of Regis Technologies. “Passing this most recent week-long inspection with flying colors highlights our ongoing ability to deliver exceptional quality and regulatory reliability. This review was conducted by a highly experienced FDA reviewer and is our second consecutive FDA audit with no Form 483’s.”
Mr. Glunz added, “The FDA has also recognized and approved Regis’ profile as a Control Testing Lab, which means that our testing results can be used in our customers’ FDA submissions without the requirement that Regis be inspected as a condition for acceptance. This gives our customers greater assurance that our work will not cause them any regulatory complications or delays.”