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Regis Technologies’ 2019 FDA Inspection Yields NAI Classification

05.08.19

Fourth consecutive inspection with no 483s

Regis Technologies has reported the successful outcome of its routine U.S. FDA inspection, which found no objectionable findings, meaning no Form 483 observations were issued. This marks the fourth consecutive inspection for Regis without incident.
 
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.
 
FDA investigators use a Form 483 to record observations of non-compliance with the agency’s Current Good Manufacturing Practices (CGMP) standards.
 
“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,” said Louis Glunz, president and chief executive officer, Regis. “Active pharmaceutical ingredients (APIs) 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.”
 
In its 80,000 square foot facility near Chicago, IL, 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 also offers pharmaceutical regulatory support services as well as access to its proprietary innovative chromatography products and services.