Regis Technologies reported that no Form 483 observations were issued following a routine FDA inspection.
On April 30, 2019, Regis Technologies reported that no Form 483 observations were issued following a four-day, onsite FDA inspection. The inspection was a routine quality systems inspection to support the company’s FDA registration and ongoing manufacture of clinical and commercial APIs.
The 80,000-ft2 facility near Chicago, IL provides synthesis, analytical, and manufacturing services to pharmaceutical and biotechnology companies. The company works with high-value intermediates and APIs from process development and scale-up through final validation and commercial manufacturing. The company also offers pharmaceutical regulatory support services as well as chromatography products and services.
