Regis Technologies Reports Successful FDA Audit with no Form 483 Observations
—Two Most Recent FDA Audits had no Form 483’s,
Highlighting Consistency of Regis’ Quality and Regulatory Excellence—
—FDA Has Recognized Regis as a Control Testing Lab, Easing Inspection Requirements for Customers—
—Visit Booth #1246 at InformEx to Learn More about Regis’ Quality Services—
Morton Grove, IL, January 21, 2014 – Regis Technologies, Inc., today reported that it successfully passed a recent U.S. Food & Drug Administration (FDA) audit with no Form 483 observations. Form 483 is used by FDA investigators to record observations of non-compliance with the agency’s current Good Manufacturing Practices (cGMP) standards. Issuance of Form 483 observations is common — in 2010, the FDA issued almost 10,000 Form 483 warnings. Regis’ GMP manufacturing facility, QC laboratory and quality systems were part of the detailed compliance inspection.
“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, CEO 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.”
Regis provides synthesis, separations and manufacturing services to pharmaceutical and biotechnology companies from its state-of-the-art cGMP facilities outside Chicago. It works with customers to advance high value intermediates and active pharmaceutical ingredients (APIs) from initial process development and scale-up through final validation and commercial manufacturing. Regis offers pharmaceutical regulatory support services, as well as access to its proprietary innovative chromatography products and services. Regis’ advanced technologies are complemented by its deep expertise gained from almost 60 years of scientific excellence.
Mr. Glunz continued, “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.”
Regis continually updates its 36,000 square foot facility that currently includes laboratories and production capabilities with eight dedicated reactor suites, individual kilo lab suites, a cryogenic reactor and a state-of-the-art quality control department. Regis has regulatory approvals in 20 countries across the globe.
To learn more about Regis, visit Booth#1246 at InformEx 2014, January 21-24, 2014 in Miami Beach, FL.
About Regis Technologies
Regis Technologies, Inc. provides custom cGMP and non-GMP synthesis, separations and manufacturing services to emerging and mid-size pharmaceutical and biotechnology companies, with the goal of expediting the development and commercialization of their new products. Regis advances its customers’ active pharmaceutical ingredients (APIs) and intermediates from initial process development and scale-up to final validation and commercial manufacturing. The company is also a leading supplier of chiral chromatography products and services and is a long-time producer of fine organic chemicals. Privately-held Regis was founded in 1956 and is headquartered outside Chicago. For more information, visit www.registech.com.