Regis Technologies’ 2019 FDA Inspection Yields NAI Classification (Zero 483s)

Regis Technologies, a contract development and manufacturing organization for small molecule active pharmaceutical ingredients, earned perfect results from its April 2019 FDA inspection.

The inspection was a routine Quality Systems inspection to support Regis’ FDA registration and ongoing manufacture of clinical and commercial active pharmaceutical ingredients (APIs). The four-day, onsite inspection resulted in an NAI (No Action Indicated) classification, which is the best that can be attained. FDA investigators use a Form 483 to record observations of non-compliance with the agency’s Current Good Manufacturing Practices (CGMP) standards.

Receiving no Form 483 observations is uncommon even in model facilities. For example, in the 2017 fiscal year, the FDA issued over 5,000 483s. Regis’ last inspection from April 2019 designates eight years of exemplary compliance, which is of the utmost importance to Regis.

Louis Glunz IV, President & CEO of Regis, commented about this latest successful FDA inspection by saying “Building CGMP-level quality into Regis’ products is critically important to both our business and customers because our commitment to quality is, ultimately, what protects the patient. Active pharmaceutical ingredients are a cornerstone of drug product safety and efficacy. The process for making APIs is very complicated and Regis works tirelessly to ensure CGMP is built into every step of the process. Keeping open, collaborative communications allows Regis to overcome these challenges and build trusting and collaborative relationships with our customers and the FDA.”

Following FDA and GMP regulations is imperative for the wellbeing of potential patients receiving drug products containing Regis-made active pharmaceutical ingredients. A safe product leads to a safe patient and so maintaining high standards is essential. Regis is continuously improving its systems via internal audits, consultation, training, and customers audits. This sentiment is followed loyally by every member of the company. Its Quality Assurance department trains all personnel on safety, GMP, and Right-to-Know policies.

Regis’ Director of Quality, Dan Weissmueller, stated, “Each and every employee plays a very important role in bringing new medicines to market. Over the course of the inspection, countless documents were sampled and reviewed for CGMP. Each record is an example of how their work is helping keep Regis products safe.”

In its 80,000 square foot facility near Chicago, Regis provides synthesis, analytical, and manufacturing services to pharmaceutical and biotechnology companies. It works with customers to advance high-value intermediates and 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 over 60 years of scientific excellence, all of which help Regis expedite drugs to market. To learn more about Regis's custom manufacturing and development services, visit registech.com. ABOUT REGIS TECHNOLOGIES: Regis Technologies, Inc. partners with pharmaceutical and biotechnology companies to help expedite their drug candidates to market.

Regis has the necessary technical and operational capabilities to fully support its clients' preclinical and clinical API needs. We offer a full range of services to support the development of our clients' lead molecules through commercialization, including process research and development, analytical and stability services, GMP API manufacturing, and preparative chromatographic separations.

With extensive organic expertise and collegiate collaborations, we also offer an innovative line of proprietary chromatography products sold throughout the world. Regis is privately owned and operated and has been in business in the Chicago area since 1956.